Device and method for unattended treatment of a patient

ABSTRACT

An unattended approach can increase the reproducibility and safety of the treatment as the chance of over/under treating of a certain area is significantly decreased. On the other hand, unattended treatment of uneven or rugged areas can be challenging in terms of maintaining proper distance or contact with the treated tissue, mostly on areas which tend to differ from patient to patient (e.g. facial area). Delivering energy via a system of active elements embedded in a flexible pad adhesively attached to the skin offers a possible solution. The unattended approach may include delivering of multiple energies to enhance a visual appearance.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of U.S. application Ser. No.17/518,243, now pending, which is a continuation-in-part ofInternational Application no. PCT/IB2021/00300, filed May 3, 2021, nowpending, which claims priority to U.S. Provisional Application No.63/019,619, filed on May 4, 2020, all of which are incorporated hereinby reference in their entirety.

FIELD OF THE INVENTION

The present invention relates to methods and apparatus for patienttreatment by means of active elements delivering electromagnetic energyand/or secondary energy in such a way that the treatment area is treatedhomogeneously without the need for manipulation of the active elementsduring the therapy.

BACKGROUND OF THE INVENTION

Skin ages with time mostly due to UV exposure—a process known asphotoaging.

Everyday exposure to UV light gradually leads to decreased skinthickness and a lower amount of the basic building proteins in theskin—collagen and elastin. The amounts of a third major skin componentare also diminished, those of hyaluronic acid. These changes appear morequickly on the visible parts of the body, most notably the face. Thereare several technologies used for facial non-invasive skin rejuvenationsuch as lasers, high-intensity focused ultrasound and radiofrequency. Itis expected that the ultrasound and RF fields also lead to an increasein levels of hyaluronic acid in the dermis.

Delivering various forms of electromagnetic energy into a patient formedical and cosmetic purposes has been widely used in the past. Thesecommon procedures for improvement of a visual appearance include, butare by no means limited to, skin rejuvenation, wrinkle removal,rhytides, skin tightening and lifting, cellulite and fat reduction,treatment of pigmented lesions, tattoo removal, soft tissue coagulationand ablation, vascular lesion reduction, face lifting, musclecontractions and muscle strengthening, temporary relief of pain, musclespasms, increase in local circulation etc.

Besides many indisputable advantages of thermal therapies, theseprocedures also bring certain limitations and associated risks. Amongothers is the limited ability of reproducible results as these arehighly dependent on applied treatment techniques and the operator'scapabilities. Moreover, if the therapy is performed inappropriately,there is an increased risk of burns and adverse events.

It is very difficult to ensure a homogeneous energy distribution if theenergy delivery is controlled via manual movement of the operator's handwhich is the most common procedure. Certain spots can be easily over- orunder-treated. For this reason, devices containing scanning or othermechanisms capable of unattended skin delivery have emerged. Thesedevices usually deliver energy without direct contact with the treatedarea, and only on a limited, well-defined area without apparentunevenness. Maintaining the same distance between the treated tissue andthe energy generator or maintaining the necessary tissue contact may bechallenging when treating uneven or rugged areas. Therefore, usage ofcommonly available devices on such specific areas that moreover differfrom patient to patient (e.g. the face) might be virtually impossible.

Facial unattended application is, besides the complications introducedby attachment to rugged areas and necessity of adaptation to the shapesof different patients, specific by its increased need for protectionagainst burns and other side effects. Although the face heals moreeasily than other body areas, it is also more exposed, leading to muchhigher requirements for treatment downtime. Another important aspect ofa facial procedure is that the face hosts the most important humansenses, whose function must not be compromised during treatment. Aboveall, eye safety must be ensured throughout the entire treatment.

The current aesthetic market offers either traditional manuallycontrolled radiofrequency or light devices enabling facial tissueheating to a target temperature in the range of 40° C.-100° C. orunattended LED facial masks whose operation is based on light effects(phototherapy) rather than thermal effects. These masks arepredominantly intended for home use and do not pose a risk to patientsof burns, overheating or overtreating. The variability in facial shapesof individual patients does not represent any issue for these masks asthe delivered energy and attained temperatures are so low that the riskof thermal tissue damage is minimized and there is no need forhomogeneous treatment. Also, due to low temperatures, it is notimportant for such devices to maintain the predetermined distancebetween the individual diodes and the patient's skin, and the shape ofthe masks is only a very approximate representation of the human face.But their use is greatly limited by the low energy and minimal to nothermal effect and they are therefore considered as a preventive toolfor daily use rather than a method of in-office skin rejuvenation withimmediate effect.

Nowadays, the aesthetic market feels the needs of the combination of theheating treatment made by electromagnetic energy delivered to theepidermis, dermis, hypodermis or adipose tissue with the secondaryenergy providing muscle contraction or muscle stimulation in the fieldof improvement of visual appearance of the patient. However, none of theactual devices is adapted to treat the uneven rugged areas like theface. In addition, the commercially available devices are usuallyhandheld devices that need to be operated by the medical professionalduring the whole treatment.

Thus it is necessary to improve medical devices providing more than onetreatment energy (e.g. electromagnetic energy and electric current),such that both energies may be delivered via different active elementsor the same active element (e.g. electrode). Furthermore, the applicatoror pad of the device needs to be attached to the patient which allowsunattended treatment of the patient and the applicator or pad needs tobe made of flexible material allowing sufficient contact with the uneventreatment area of the body part of the patient.

SUMMARY OF THE INVENTION

In order to enable well defined unattended treatment of the uneven,rugged areas of a patient (e.g. facial area) while preserving safety,methods and devices of minimally invasive to non-invasiveelectromagnetic energy delivery via a single or a plurality of activeelements have been proposed.

The patient may include skin and a body part, wherein a body part mayrefer to a body area.

The desired effect of the improvement of visual appearance of thepatient may include tissue (e.g. skin) heating in the range of 37.5° C.to 55° C., tissue coagulation at temperatures of 50° C. to 70° C., ortissue ablation at temperatures of 55° C. to 130° C. depending on thepatient. Various patients and skin conditions may require differenttreatment approaches—higher temperatures allow better results with fewersessions but require longer healing times while lower temperaturesenable treatment with no downtime but limited results within moresessions. Another effect of the heating may lead to decreasing thenumber of the fat cells.

Another desired effect may be muscle contraction causing musclestimulation (e.g. strengthening or toning) for improving the visualappearance of the patient.

An arrangement for contact or contactless therapy has been proposed.

For contact therapy, the proposed device and methods comprise at leastone electromagnetic energy generator inside a main unit that generatesan electromagnetic energy which is delivered to the treatment area viaat least one active element attached to the skin. At least one activeelement may be embedded in a pad made of flexible material that adaptsto the shape of the rugged surface. An underside of the pad may includean adhesive layer allowing the active elements to adhere to thetreatment area and to maintain necessary tissue contact. Furthermore,the device may employ a safety system capable of adjusting one or moretherapy parameters based on the measured values from at least onesensor, e.g. thermal sensors or impedance measurement sensors capable ofmeasuring quality of contact with the treated tissue.

For contactless therapy, the proposed device and methods comprise atleast one electromagnetic energy generator inside a main unit thatgenerates an electromagnetic energy which is delivered to the treatmentarea via at least one active element located at a defined distance fromthe tissue to be treated. A distance of at least one active element fromthe treatment area may be monitored before, throughout the entiretreatment or post-treatment. Furthermore, the device may employ a safetysystem capable of adjusting one or more therapy parameters based on themeasured values from at least one sensor, for example one or moredistance sensors. Energy may be delivered by a single or a plurality ofstatic active elements or by moving a single or a plurality of activeelements throughout the entire treatment area, for example via abuilt-in automatic moving system, e.g. an integrated scanner. Treatmentareas may be set by means of laser sight—the operator may mark the areato be treated prior to the treatment.

The active element may deliver energy through its entire surface or bymeans of a so-called fractional arrangement when the active partincludes a matrix formed by points of defined size. These points may beseparated by inactive (and therefore untreated) areas that allow fastertissue healing. The points surface may make up from 1% to 99% of theactive element area.

The electromagnetic energy may be primarily generated by a laser, laserdiode module, LED, flash lamp or incandescent light bulb or byradiofrequency generator for causing the heating of the patient.Additionally, an acoustic energy or electric or electromagnetic energy,which does not heat the patient, may be delivered simultaneously,alternately or in overlap with the primary electromagnetic energy.

Additionally, the heating of the patient may be provided by a heatedfluid, magnetic field, ultrasound, or by a heating element (e.g.resistance wire or thermoelectric cooler (TEC)).

The active element may deliver more than one energy simultaneously (atthe same time), successively or in overlap. For example, the activeelement may deliver a radiofrequency energy and subsequently an electricenergy (electric current). In another example, the active element maydeliver the radiofrequency energy and the electric energy at the sametime.

Furthermore the device may be configured to deliver the electromagneticfield by at least one active element and simultaneously (at the sametime) deliver e.g. electric energy by a different elements.

The proposed methods and devices may provide heating of tissue,contractions of muscles or the combination of heating and musclecontractions.

In one aspect, the proposed device may provide three different types ofenergies. For example, radiofrequency energy, electric current, andmagnetic field; radiofrequency energy, electric current, and pressurepulses; radiofrequency energy, magnetic field, and pressure pulses; orany other possible combinations of energies provided by the proposeddevice.

Thus the proposed methods and devices may lead to improvement of avisual appearance including, but by no means limited to a proper skinrejuvenation, wrinkle removal, skin tightening and lifting, celluliteand fat reduction, treatment of pigmented lesions, rhytides, tattooremoval, soft tissue coagulation and ablation, vascular lesionsreduction, temporary relief of pain, muscle spasms, increase in localcirculation, etc. of uneven rugged areas without causing further harm toimportant parts of the patient's body, e.g. nerves or internal organs.The proposed method and devices may lead to an adipose tissue reduction,e.g. by fat cells lipolysis or apoptosis.

Furthermore, the proposed methods and devices may lead to improvement ofa visual appearance, e.g. tissue rejuvenation via muscle strengtheningor muscle toning through muscle contractions caused by electric currentor electromagnetic energy and via elastogenesis and/or neocolagenesisand/or relief of pain and/or muscle spasms and/or increase in localcirculation through heating by radiofrequency energy.

Alternatively, the proposed devices and methods may be used forpost-surgical treatment, e.g. after liposuction, e.g. for treatmentand/or healing of the wounds caused by surgery.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a block diagram of an apparatus for contact therapy.

FIG. 2 is an illustration of an apparatus for contact therapy.

FIG. 3A represents pad shapes and layout.

FIG. 3B represents pad shapes and layout.

FIG. 3C represents one possible pad shape and layout for treatment of aforehead.

FIG. 3D represent one possible pad shape and layout for treatment of acheek.

FIG. 3E represents one possible pad shape and layout for treatment of acheek.

FIG. 3F represent one possible pad shape and layout for treatment of aforehead.

FIG. 4A, represent side views of the pad intended for contact therapy.

FIG. 4B, represent side views of the pad intended for contact therapy.

FIG. 4C, represent side views of the pad intended for contact therapy.

FIG. 4D represent side views of the pad intended for contact therapy.

FIG. 4E represents a cross section of one possible pad structure

FIG. 5A represents a top view of one variant of the pad.

FIG. 5B represents a detail view of one possible arrangement of the slotin the substrate.

FIG. 6 shows one variant of energy delivery by switching multiple activeelements.

FIG. 7 shows a block diagram of an apparatus for contactless therapy.

FIG. 8 is an illustration of an apparatus for contactless therapy.

FIG. 9A is an illustration of the framed grated electrode.

FIG. 9B is an illustration of another framed grated electrode.

FIG. 9C is an illustration of a framed grated electrode with thinningconductive lines.

FIG. 9D is an illustration of a non-framed grated electrode.

FIG. 9E is an illustration of an electrode with openings.

FIG. 9F is one possible illustration of an electrode.

FIG. 9G is another illustration of an electrode.

FIG. 9H is another illustration of an electrode.

FIG. 9I illustrates a detail of a framed grated electrode

FIG. 10 is an illustration of a forehead pad treatment.

FIG. 11A illustrates a continual mode of electromagnetic energy

FIG. 11B illustrates a pulse mode of electromagnetic energy

FIG. 11C illustrates a pulse mode of secondary energy

FIG. 11 D illustrates possible modulations of energy establishing energyenvelopes

DETAILED DESCRIPTION

The presented methods and devices may be used for stimulation and/ortreatment of a tissue, including but not limited to skin, epidermis,dermis, hypodermis or muscles. The proposed apparatus is designed forminimally to non-invasive treatment of one or more areas of the tissueto enable well defined unattended treatment of the uneven, rugged areas(e.g. facial area) by electromagnetic energy delivery via a single or aplurality of active elements without causing further harm to importantparts of the patient's body, e.g. nerves or internal organs.

Additionally the presented methods and devices may be used to stimulatebody parts or body areas like head, neck, bra fat, love handles, torso,back, abdomen, buttocks, thighs, calves, legs, arms, forearms, hands,fingers or body cavities (e.g. vagina, anus, mouth, inner ear etc.).

The proposed methods and devices may include a several protocolsimproving of visual appearance, which may be preprogramed in the controlunit (e.g. CPU—central processing unit, which may include a flex circuitor a printed circuit board and may include a microprocessor or memoryfor controlling the device).

The desired effect may include tissue (e.g. a surface of the skin)heating (thermal therapy) in the range of 37.5° C. to 55° C. or in therange of 38° C. to 53° C. or in the range of 39° C. to 52° C. or in therange of 40° C. to 50° C. or in the range of 41° C. to 45° C., tissuecoagulation at temperatures in the range of 50° C. to 70° C. or in therange of 51° C. to 65° C. or in the range of 52° C. to 62° C. or in therange of 53° C. to 60° C. or tissue ablation at temperatures in therange of 55° C. to 130° C. or in the range of 58° C. to 120° C. or inthe range of 60° C. to 110° C. or in the range of 60° C. to 100° C. Thedevice may be operated in contact or in contactless methods. For contacttherapy a target temperature of the skin may be typically within therange of 37.5° C. to 95° C. or in the range of 38° C. to 90° C. or inthe range of 39° C. to 85° C. or in the range of 40° C. to 80° C. whilefor contactless therapy a target temperature of the skin may be in therange of 37.5° C. to 130° C. or in the range of 38° C. to 120° C. or inthe range of 39° C. to 110° C. or in the range of 40° C. to 100° C. Thetemperature within the range of 37.5° C. to 130° C. or in the range of38° C. to 120° C. or in the range of 39° C. to 110° C. or in the rangeof 40° C. to 100° C. may lead to stimulation of fibroblasts andformation of connective tissue—e.g. collagen, elastin, hyaluronic acidetc. Depending on the target temperature, controlled tissue damage istriggered, physiological repair processes are initiated, and new tissueis formed. Temperatures within the range of 37.5° C. to 130° C. or inthe range of 38° C. to 120° C. or in the range of 39° C. to 110° C. orin the range of 40° C. to 100° C. may further lead to changes in theadipose tissue. During the process of apoptosis caused by hightemperatures, fat cells come apart into apoptotic bodies and are furtherremoved via the process of phagocytosis. During a process callednecrosis, fat cells are ruptured due to high temperatures, and theircontent is released into an extracellular matrix. Both processes maylead to a reduction of fat layers enabling reshaping of the face.Removing fat from the face may be beneficial for example in areas likesubmentum or cheeks.

Another desired effect may include tissue rejuvenation, e. g. musclestrengthening through the muscle contraction caused by electric orelectromagnetic energy, which doesn't heat the patient, or the musclerelaxation caused by a pressure massage. The combined effect of musclecontractions via electric energy and tissue (e.g. skin) heating byelectromagnetic field in accordance to the description may lead tosignificant improvement of visual appearance.

FIG. 1 and FIG. 2 are discussed together. FIG. 1 shows a block diagramof an apparatus 1 for contact therapy. FIG. 2 is an illustration of anapparatus 1 for contact therapy. The apparatus 1 for contact therapy maycomprise two main blocks: main unit 2 and a pad 4. Additionally, theapparatus 1 may comprise interconnecting block 3 or neutral electrode 7.However, the components of interconnecting block 3, may be implementedinto the main unit 2.

Main unit 2 may include one or more generators: a primaryelectromagnetic generator 6, which may preferably deliver radiofrequencyenergy in the range of 10 kHz to 300 GHz or 300 kHz to 10 GHz or 400 kHzto 6 GHz, or in the range of 100 kHz to 550 MHz or 250 kHz to 500 MHz or350 kHz to 100 MHz or 400 kHz to 80 MHz, a secondary generator 9 whichmay additionally deliver electromagnetic energy, which does not heat thepatient, or deliver electric current in the range of 1 Hz to 10 MHz or 5Hz to 5 MHz or in the range of 10 Hz to 1 MHz or in the range of 20 Hzto 1 kHz or in the range of 40 Hz to 500 Hz or in the range of 50 Hz to300 Hz and/or an ultrasound emitter 10 which may furthermore deliver anacoustic energy with a frequency in the range of 20 kHz to 25 GHz or 20kHz to 1 GHz or 50 kHz to 250 MHz or 100 kHz to 100 MHz. In addition,the frequency of the ultrasound energy may be in the range of 20 kHz to80 MHz or 50 kHz to 50 MHz or 150 kHz to 20 MHz.

The output power of the radiofrequency energy may be less than or equalto 450 W, 300 W, 250 W or 220 W. Additionally, the radiofrequency energyon the output of the primary electromagnetic generator 6 (e.g.radiofrequency generator) may be in the range of 0.1 W to 400 W, or inthe range of 0.5 W to 300 W or in the range of 1 W to 200 W or in therange of 10 W to 150 W. The radiofrequency energy may be applied in orclose to the ISM bands of 6.78 MHz, 13.56 MHz, 27.12 MHz, 40.68 MHz,433.92 MHz, 915 MHz, 2.45 GHz and 5.8 GHz.

The primary generator 6 may also provide more than one radiofrequencyenergy with different parameters. As one non-limiting example, theprimary generator may generate one radiofrequency energy with frequencyin a range of 100 kHz to 550 MHz, 250 kHz to 500 MHz, 350 kHz to 100MHz, or 400 kHz to 80 MHz and a second radiofrequency energy with afrequency in a range of 400 kHz to 300 GHz, 500 kHz to 30 GHz, 600 kHzto 10 GHz, or 650 kHz to 6 GHz.

Additionally, the heating of the patient may be provided by a heatedfluid. In one aspect, the fluid may be heated in the heat generatorinside the main unit 2 and may be coupled to the pad 4 by a fluidconduit, which may be in a form of a closed loop. When the heated fluidis delivered, e.g. via a pump, fan or other fluid delivery system,towards the patient via the active element in the pad 4, it dissipatesits heat, and then the fluid is brought back to the heat generator whereit is heated again. The fluid may be in form of a liquid (e.g. water, oroil) or a gas (e.g. air, nitrogen, carbon dioxide, carbon oxide, orother suitable gases know in the prior art). The fluid may be heated tothe temperature in a range of 37.5° C. to 100° C., in a range of 38° C.to 64° C., or in a range of 40° C. to 57° C. In one aspect, the heatedfluid may be supplementary heating energy for the electromagneticheating energy or vice versa.

In one aspect, the heating may be provided by a heating element, forexample a resistance wire or a thermoelectric cooler (TEC) which may beconnected to primary electromagnetic generator 6 or secondary generator9. In this aspect, the active element may be the heating element. Theheating element may have the temperature on its surface in a range of37.5° C. to 68° C., in a range of 38° C. to 62° C., or in a range of 39°C. to 50° C.

Main unit 2 may further comprise a human machine interface 8 representedby a display, buttons, a keyboard, a touchpad, a touch panel or othercontrol members enabling an operator to check and adjust therapy andother device parameters. For example, it may be possible to set thepower, treatment time or other treatment parameters of each generator(primary electromagnetic generator 6, secondary generator 9 andultrasound emitter 10) independently. The human machine interface 8 maybe connected to control unit 11 (e.g. CPU). The power supply 5 locatedin the main unit 2 may include a transformer, disposable battery,rechargeable battery, power plug or standard power cord. The outputpower of the power supply 5 may be in the range of 10 W to 600 W, or inthe range of 50 W to 500 W, or in the range of 80 W to 450 W.

In addition the human machine interface 8 may also display informationabout the applied therapy type, remaining therapy time and main therapyparameters.

Interconnecting block 3 may serve as a communication channel between themain unit 2 and the pad 4. It may be represented by a simple devicecontaining basic indicators 17 and mechanisms for therapy control.Indicators 17 may be realized through the display, LEDs, acousticsignals, vibrations or other forms capable of providing adequate noticeto an operator and/or the patient. Indicators 17 may indicate actualpatient temperature, contact information or other sensor measurements aswell as a status of a switching process between the active elements,quality of contact with the treated tissue, actual treatment parameters,ongoing treatment, etc. Indicators 17 may be configured to warn theoperator in case of suspicious therapy behavior, e.g. temperature out ofrange, improper contact with the treated tissue, parametersautomatically adjusted etc. Interconnecting block 3 may be used as anadditional safety feature for heat-sensitive patients. It may containemergency stop button 16 so that the patient can stop the therapyimmediately anytime during the treatment. Switching circuitry 14 may beresponsible for switching between active elements or for regulation ofenergy delivery from primary electromagnetic generator 6, secondarygenerator 9 or ultrasound emitter 10. The rate of switching betweenactive elements 13 may be dependent on the amount of delivered energy,pulse length etc, and/or on the speed of switching circuitry 14 andcontrol unit 11 (e.g. CPU). The switching circuitry 14 may include relayswitch, transistor (bipolar, PNP, NPN, FET, JFET, MOSFET) thyristor,diode, optical switch, opto-electrical switch or opto-mechanical switchor any other suitable switch know in the prior art. The switchingcircuitry in connection with the control unit 11 (e.g. CPU) may controlthe switching between the primary electromagnetic energy generated bythe primary electromagnetic generator 6 and the secondary energygenerated by the secondary generator 9 on the at least one activeelement 13.

Additionally, the interconnecting block 3 may contain the primaryelectromagnetic generator 6, the secondary generator 9 or ultrasoundemitter 10 or only one of them or any combination thereof.

In one not limiting aspect, the main unit 2 may comprise the primaryelectromagnetic generator 6, the interconnecting block 3 may comprisethe secondary generator 9, and ultrasound emitter 10 may not be presentat all.

The control unit 11 (e.g. CPU) controls the primary electromagneticgenerator 6 such that the primary electromagnetic energy may bedelivered in a continuous mode (CM) or a pulse mode to the at least oneactive element, having a fluence in the range of 10 mJ/cm² to 50 kJ/cm²or in the range of 100 mJ/cm² to 10 kJ/cm² or in the range of 0.5 J/cm²to 1 kJ/cm². The electromagnetic energy may be primarily generated by alaser, laser diode module, LED, flash lamp or incandescent light bulb orby radiofrequency generator for causing the heating of the patient. TheCM mode may be operated for a time interval in the range of 0.05 s to 60min or in the range of 0.1 s to 45 min or in the range of 0.2 s to 30min. The pulse duration of the energy delivery operated in the pulseregime may be in the range of 0.1 ms to 10 s or in the range of 0.2 msto 7 s or in the range of 0.5 ms to 5 s. The primary electromagneticgenerator 6 in the pulse regime may be operated by a control unit 11(e.g. CPU) in a single shot mode or in a repetition mode. The frequencyof the repetition mode may be in the range of 0.05 to 10 000 Hz or inthe range of 0.1 to 5000 Hz or in the range of 0.3 to 2000 Hz or in therange of 0.5 to 1000 Hz. Alternatively, the frequency of the repetitionmode may be in the range of 0.1 kHz to 200 MHz or in the range of 0.5kHz to 150 MHz or in the range of 0.8 kHz to 100 MHz or in the range of1 kHz to 80 MHz. The single shot mode may mean generation of just oneelectromagnetic pulse of specific parameters (e.g. intensity, duration,etc.) for delivery to a single treatment area. The repetition mode maymean generation of an electromagnetic pulses, which may have thespecific parameters (e.g. intensity, duration, etc.), with a repetitionrate of the above-mentioned frequency for delivery to a single treatmentarea. The control unit (e.g. CPU) 11 may provide treatment control suchas stabilization of the treatment parameters including treatment time,power, duty cycle, time period regulating switching between multipleactive elements, temperature of the device 1 and temperature of theprimary electromagnetic generator 6 and secondary generator 9 orultrasound emitter 10. The control unit 11 (e.g. CPU) may drive andprovide information from the switching circuitry 14. The control unit 11(e.g. CPU) may also receive and provide information from sensors locatedon or in the pad 4 or anywhere in the device 1. The control unit (e.g.CPU) 11 may include a flex circuit or a printed circuit board and mayinclude a microprocessor or memory for controlling the device.

FIG. 11A shows the delivery of the electromagnetic energy in thecontinuous mode. The electromagnetic waves 1101 (e.g. sinusoidalradiofrequency waves) are delivered continuously from the start time t0with the continuous electromagnetic envelope 1103 (e.g. radiofrequencyenvelope). FIG. 11B shows the delivery of the electromagnetic energy inthe pulse mode. The electromagnetic waves 1101 (e.g. sinusoidalradiofrequency waves) are delivered in electromagnetic pulses 1102 (e.g.radiofrequency pulses). The electromagnetic pulses 1102 may create atleast one electromagnetic envelope 1105 (e.g. radiofrequency envelope),which is depicted as a rectangular electromagnetic envelope 1105 in FIG.11B. The electromagnetic envelopes (1103, 1105) may have various shapes,e.g. circular, semicircular, sinusoidal, rectangular, triangular,trapezoidal, or polygonal shape.

The electromagnetic waves 1101 (e.g. radiofrequency waves) may bemodulated in amplitude or frequency within one electromagnetic pulse(1102 or 1103) or may be modulated differently in differentelectromagnetic pulses. For example, a first electromagnetic pulse mayhave a rectangular envelope and a second electromagnetic pulse followingthe first electromagnetic pulse may have a sinusoidal envelope. Thepause time 1104 between two consecutive pulses 1102 may be in the rangeof 1 μs to 1 s, in the range of 500 μs to 500 ms, in the range of 1 msto 450 ms, or in the range of 100 ms to 450 ms. The pause time 1104 is atime when there are no electromagnetic waves provided by the device.

The control unit (e.g. CPU) 11 may control the secondary generator 9such that secondary energy (e.g electric current or magnetic field) maybe delivered in a continuous mode (CM) or a pulse mode to the at leastone active element, having a fluence in the range of 10 mJ/cm² to 50kJ/cm² or in the range of 100 mJ/cm² to 10 kJ/cm² or in the range of 0.5J/cm² to 1 kJ/cm² on the surface of the at least one active element.Applying the secondary energy to the treatment area of the patient maycause a muscle contractions of the patient. The CM mode may be operatedfor a time interval in the range of 0.05 s to 60 min or in the range of0.1 s to 45 min or in the range of 0.2 s to 30 min. The pulse durationof the delivery of the secondary energy operated in the pulse regime maybe in the range of 0.1 μs to 10 s or in the range of 0.2 μs to 1 s or inthe range of 0.5 μs to 500 ms, or in the range of 0.5 to 10 s or in therange of 1 to 8 s or in the range of 1.5 to 5 s or in the range of 2 to3 s. The secondary generator 9 in the pulse regime may be operated by acontrol unit 11 (e.g. CPU) in a single shot mode or in a repetitionmode. The frequency of the repetition mode may be in the range of 0.1 to12 000 Hz or in the range of 0.1 to 8000 Hz or in the range of 0.1 to5000 Hz or in the range of 0.5 to 1000 Hz.

FIG. 11C shows the delivery of the secondary energy in the pulse mode.The secondary energy is delivered in secondary energy pulses 1111 (e.g.biphasic rectangular electric current pulses) which are providedcontinuously from the start time t0 to the end time t1, creating asecondary energy envelope 1112 (e.g. electric current envelope). Onepossible secondary energy pulse 1111 (e.g. electric pulse) ishighlighted in the doted oval in FIG. 11C. The secondary energy pulses1111 may be delivered uniformly one after another, or with a secondaryenergy pulse pause time 1113 between the secondary energy pulses 1111 asseen in FIG. 11C. The secondary energy pulse pause time 1113 means atime when there is no secondary energy delivered/generated between twoconsecutive secondary energy pulses 1111. A duty cycle of the secondaryenergy pulse 1111 and the secondary energy pulse pause time 1113 may bein the range of 0.1% to 99%, in the range of 0.5% to 50%, in the rangeof 0.7% to 33%, in the range of 1% to 17%, or in the range of 1.5% to10%. In one aspect, the secondary energy pulse pause time 1113 may be inthe range of 80 μs to 100 ms or in the range of 160 μs to 50 ms or inthe range of 250 μs to 10 ms or in the range of 0.5 ms to 7 ms.

The secondary energy (e.g. electric current pulses or magnetic fieldpulses) generated by the secondary generator 9 may be modulated infrequency or amplitude in the same way as the electromagnetic energy(e.g. radiofrequency waves) generated by the primary generator 6,creating different shapes of the secondary energy envelopes (e.g.electric current envelopes) as seen in FIG. 11D. For example, a firsttriangle envelope 1112 a comprises series of secondary energy pulses1111 that are modulated in amplitude such, that each consecutivesecondary energy pulse has a higher amplitude than the previous one. Asecond rectangular envelope 1112 b comprises series of secondary energypulses 1111 having the same amplitude. As one can see from FIG. 11D theconsecutive envelopes 1112 a and 1112 b may be separated by an envelopepause time, which is a time when there are no secondary energy pulsesgenerated/delivered and no envelope established. In one aspect, theenvelope pause time 1114 is longer than pulse pause time 1113. Inanother aspect, the envelope pause time 1114 has at least a length ofthe secondary energy pulse 1111 plus the secondary energy pulse pausetime 1113. In one aspect, the secondary energy may be modulated withinone secondary energy envelope 1112, and the envelopes may be the samefor the whole treatment, e.g. only trapezoid envelope may be deliveredthrough the treatment. In another aspect, the secondary energy may bemodulated differently for different secondary energy envelopes 1112delivered during the treatment, e.g. increasing envelope may bedelivered first, than the rectangle envelope may be delivered secondlyand then the decreasing triangle envelope may be delivered, wherein theenvelopes are separated by the envelope pause time 1114. The secondaryenergy envelopes 1112 may have a shape of a sinus, triangle, conic,rectangle, trapezoid or polygon.

The secondary energy (e.g. electric current or magnetic field) may bealso modulated in frequency within the secondary energy envelope 1112,which may cause an increasing or decreasing treatment response in thepatient's body. For example, the electric current or the magnetic fieldmay be modulated such that the frequency of secondary energy pulses 1111is increasing, which may cause an intensity of muscle contractions toincrease. Then the frequency of the secondary energy pulses 1111 may beconstant causing the same intensity of muscle contractions and then thefrequency of the secondary energy pulses 1111 may be decreasing causingdecreasing intensity of the muscle contractions. The same principle maybe used for the primary electromagnetic energy, thus creating, forexample, series of increasing, constant and decreasing amplitudes of theelectromagnetic energy, or series of increasing, constant and decreasingfrequencies of the electromagnetic waves, which both may cause anincreasing, constant and decreasing heating of the tissue of thepatient.

Alternatively, it may be also possible to use only one generator togenerate one type of energy/signal and one or more converters thatconvert the energy/signal to other one or more types of energy/signal.For example, the primary generator may generate a radiofrequency signalthat is converted to electric current by the convertor (e.g. by aconverting electric circuit).

The proposed device may be multichannel device allowing the control unit(e.g. CPU) 11 to control the treatment of more than one treated area atonce.

Alternatively, the interconnecting block 3 may not be a part of thedevice 1, and the control unit (e.g. CPU) 11, switching circuitry 14,indicators 17 and emergency stop button 16 may be a part of the mainunit 2 or pad 4. In addition, some of the control unit (e.g. CPU) 11,switching circuitry 14, indicators 17 and emergency stop button 16 maybe a part of the main unit 2 and some of them part of pad 4, e.g.control unit (e.g. CPU) 11, switching circuitry 14 and emergency stopbutton 16 may be part of the main unit 2 and indicators 17 may be a partof the pad 4.

Pad 4 represents the part of the device which may be in contact with thepatient's skin during the therapy. The pads 4 may be made of flexiblesubstrate material—for example polymer-based material, polyimide (PI)films, polytetrafluoroethylene (PTFE, e.g., Teflon®), epoxy,polyethylene terephthalate (PET), polyamide or polyethylene (PE) foamwith an additional adhesive layer on an underside, e.g. a hypoallergenicadhesive gel (hydrogel) or adhesive tape that may be bacteriostatic,non-irritating, or water-soluble. The substrate may also be asilicone-based substrate. The substrate may also be made of a fabric,e.g. non-woven fabric. The adhesive layer may have the impedance for acurrent at a frequency of 500 kHz in the range of 1 to 150Ω or in therange of 5 to 130Ω or in the range of 10 to 100Ω, and the impedance fora current at a frequency of 100 Hz or less is three times or more theimpedance for a current at a frequency of 500 kHz. The adhesive hydrogelmay be made of a polymer matrix or mixture containing water, apolyhydric alcohol, a polyvinylpyrrolidone, a polyisocyanate component,a polyol component or has a methylenediphenyl structure in the mainchain. Additionally, a conductive adhesive may be augmented withmetallic fillers, such as silver, gold, copper, aluminum, platinum ortitanium or graphite that make up 1 to 90% or 2 to 80% or 5 to 70% ofadhesive. The adhesive layer may be covered by “ST-gel®” or “Tensive®”conductive adhesive gel which is applied to the body to reduce itsimpedance, thereby facilitating the delivery of an electric shock.

The adhesive layer, e.g. hydrogel may cover exactly the whole surface ofthe pad facing the body area of the patient. The thickness of thehydrogel layer may be in the range of 0.1 to 3 mm or in the range of 0.3to 2 mm or in the range of 0.4 to 1.8 mm or in the range of 0.5 to 1.5mm.

The adhesive layer under the pad 4 may mean that the adhesive layer isbetween the surface of the pad facing the patient and the body of thepatient. The adhesive layer may have impedance 1.1 times, 2 times, 4times or up to 10 times higher than the impedance of the skin of thepatient under the pad 4. A definition of the skin impedance may be thatit is a portion of the total impedance, measured between twoequipotential surfaces in contact with the epidermis, that is inverselyproportional to the electrode area, when the internal current flux pathis held constant. Data applicable to this definition would beconveniently recorded as admittance per unit area to facilitateapplication to other geometries. The impedance of the adhesive layer maybe set by the same experimental setup as used for measuring the skinimpedance. The impedance of the adhesive layer may be higher than theimpedance of the skin by a factor in the range of 1.1 to 20 times or 1.2to 15 times or 1.3 to 10 times.

The impedance of the adhesive layer may have different values for thedifferent types of energy delivered to the patient, e.g. the impedancemay be different for radiofrequency and for electric current delivery.The impedance of the hydrogel may be in the range of 100 to 2000 Ohms orin the range of 150 to 1800 Ohms or 200 to 1500 Ohms or 300 to 1200 Ohmsin case of delivery of the electric current (e.g. duringelectrotherapy). In one aspect, the impedance of an adhesive layer (e.g.hydrogel) for AC current at 1 kHz may be in the range of 100 to 5000Ohms, or of 200 to 4500 Ohms, or of 500 to 4000 Ohms, or of 1000 to 3000Ohms, or of 1200 to 2800 Ohms, or of 1500 to 2500 Ohms. In anotheraspect, the impedance of the adhesive layer (e.g. hydrogel) for ACcurrent at 10 Hz may be in the range of 2000 to 4000 Ohms, or of 2300 to3700 Ohms, or of 2500 to 3500 Ohms.

The electric conductivity of the adhesive layer at radiofrequency of 3.2MHz may be in the range of 20 to 200 mS/m or in the range of 50 to 140mS/m or in the range of 60 to 120 mS/m or in the range of 70 to 100mS/m.

Alternatively, the adhesive layer may be a composition of more elements,wherein some elements may have suitable physical properties (referred toherein as adhesive elements), e.g. proper adhesive and/or conductivityand/or impedance and/or cooling properties and so on; and some elementsmay have nourishing properties (referred to herein as nourishingelements), e.g. may contain nutrients, and/or vitamins, and/or minerals,and/or organic and/or inorganic substances with nourishing effect, whichmay be delivered to the skin of the patient during the treatment. Thevolumetric ratio of adhesive elements to nourishing elements may be inthe range of 1:1 to 20:1, or of 2:1 to 10:1, or of 3:1 to 5:1, or of 5:1to 50:1, or of 10:1 to 40:1, or of 15:1. In one aspect, the adhesivelayer composition may contain a hydrogel as an adhesive element and ahyaluronic acid as a nourishing element. In another aspect, the adhesivelayer composition may contain a hydrogel as an adhesive element and oneor more vitamins as nourishing elements. In another aspect, the adhesivelayer composition may contain a hydrogel as an adhesive element and oneor more minerals as nourishing elements.

In one aspect, the nourishing element may be released continuously byitself during the treatment. In another aspect, the nourishing elementmay be released due to delivery of a treatment energy (e.g. heat,radiofrequency, light, electric current, magnetic field or ultrasound),which may pass through the nourishing element and thus cause its releaseto the skin of the patient.

The pad comprising the adhesive layer may be configured for a single use(disposable).

Alternatively, the pad may not contain the adhesive layer and maycomprise at least the substrate and the active element (e.g. electrode).

In one aspect, at the beginning of the treatment the adhesive layer(e.g. hydrogel) may be externally applied on the surface of the patientprior to the application of the pad. The pad is then coupled to theadhesive layer. In another aspect, a covering layer (e.g. thin foil) maybe inserted between the adhesive layer and the pad. The foil may beadhesive on one side or on both sides and provide a coupling of the padwith the body of the patient. In this case, it may be possible to usethe same pad more than once as the covering layer guarantee the hygienicsafety of the pad.

In another aspect, layers of some other substance may be applied on thesurface of the patient prior to the application of the pad and the padis coupled to this layer. This may be active substance layer, coolinglayer (e.g. cooling gel), partially adhesive layer, or any othernon-adhesive layer. In one aspect, the active substance layer maycomprise e.g. hyaluronic acid, one or more vitamins, one or moreminerals or any of their combination. The active substance from theactive substance layer may be in form of a solution (e.g. gel or cream)applied on the patient or may be coupled to the covering layer (e.g.thin foil), which is then attached to the skin of the patient. Theactive substance may be continuously released into the skin due to atleast one energy provided by the pad (e.g. radiofrequency energy, orheat, or electric current or magnetic field, etc.) throughout thetreatment. In another aspect, the active substance may be released intothe skin at the beginning, at some time during, or at the end of thetreatment in order to visually improve the skin.

The pad 4 may also have a sticker on a top side of the pad. The top sideis the opposite side from the underside (the side where the adhesivelayer may be deposited) or in other words the top side is the side ofthe pad that is facing away from the patient during the treatment. Thesticker may have a bottom side and a top side, wherein the bottom sideof the sticker may comprise a sticking layer and the top side of thesticker may comprise non-sticking layer (eg. polyimide (PI) films, PTFE(e.g. Teflon®), epoxy, polyethylene terephthalate (PET), polyamide or PEfoam, PE film or PVC foam). Thus the sticker may be made of two layers(top non-sticking and bottom sticking layer). The sticker covers the topside of the pad and may also cover some sensors situated on the top sideof the pad (e.g. thermal sensors).

The sticker may have the same shape as the pad 4 or may have additionaloverlap over the pad, e.g., extend beyond the shape of the pad 4. Thesticker may be bonded to the pad such that the sticking layer of thebottom side of the sticker is facing toward the top side of the pad 4.The top side of the sticker facing away from the pad 4 may be made of anon-adhesive layer. The linear dimension of the sticker with additionaloverlap may exceed the corresponding dimension of the pad in the rangeof 0.1 to 10 cm, or in the range of 0.1 to 7 cm, or in the range of 0.2to 5 cm, or in the range of 0.2 to 3 cm, or in the range of 0.3 to 1 cm.The area of the sticker (with the overlap) may be 0.5% to 50%, 1% to40%, 1.5% to 33%, 2% to 25% 3% to 20%, or 5% to 15% larger than the areaof the pad. This overlap may also comprise an adhesive layer and may beused to form additional and more proper contact of the pad with thepatient. The thickness of the sticker may be in the range of 0.05 to 3mm or in the range of 0.1 to 2 mm or in the range of 0.5 to 1.5 mm. Thetop side of the sticker may have a printed inscription for easyrecognition of the pad, e.g. the brand of the manufacturer or theproposed treated body area.

In one aspect, the adhesive layer, e.g. hydrogel, on the underside ofthe pad facing the body area of the patient may cover the whole surfaceof the pad and even overlap the surface of the pad and cover at leastpartially the overlap of the sticking layer. In another aspect, theunderside of the adhesive layer and/or the overlap of the sticker (bothparts facing towards the patient) may be covered by a liner, which maybe removed just before the treatment. The liner protects the adhesivelayer and/or the overlap of the sticker, thus when the liner is removedthe proper adhesion to the body area of the patient is ensured.

Alternatively, the pad 4 may comprise at least one suction opening, e.g.small cavities or slits adjacent to active elements or the activeelement may be embedded inside a cavity. The suction opening may beconnected via connecting tube to a pump which may be part of the mainunit 2. When the suction opening is brought into contact with the skin,the air sucked from the suction opening flows toward the connecting tubeand the pump and the skin may be slightly sucked into the suctionopening. Thus by applying a vacuum the adhesion of pad 4 may beprovided. Furthermore, the pad 4 may comprise the adhesive layer and thesuction openings for combined stronger adhesion.

In addition to the vacuum (negative pressure), the pump may also providea positive pressure by pumping the fluid to the suction opening. Thepositive pressure is pressure higher than atmospheric pressure and thenegative pressure or vacuum is lower than atmospheric pressure.Atmospheric pressure is a pressure of the air in the room during thetherapy.

The pressure (positive or negative) may be applied to the treatment areain pulses providing a massage treatment. The massage treatment may beprovided by one or more suction openings changing pressure value to thepatient's soft tissue in the meaning that the suction opening applydifferent pressure to patient tissue. Furthermore, the suction openingsmay create a pressure gradient in the soft tissue without touching theskin. Such pressure gradients may be targeted on the soft tissue layer,under the skin surface and/or to different soft tissue structure.

Massage accelerates and improves treatment therapy by electromagneticenergy, electric energy or electromagnetic energy which does not heatthe patient, improves blood and/or lymph circulation, angioedema,erythema effect, accelerates removing of the fat, accelerate metabolism,accelerates elastogenesis and/or neocolagenesis.

Each suction opening may provide pressure by a suction mechanism,airflow or gas flow, liquid flow, pressure provided by an objectincluded in the suction opening (e.g. massaging object, pressure cellsetc.) and/or in other ways.

Pressure value applied on the patient's tissue means that a suctionopening providing massaging effect applies positive, negative and/orsequentially changing positive and negative pressure on the treatedand/or adjoining patient's tissue structures and/or creates a pressuregradient under the patient's tissue surface

Massage applied in order to improve body liquid flow (e.g. lymphdrainage) and/or relax tissue in the surface soft tissue layers may beapplied with pressure lower than during the massage of deeper softtissue layers. Such positive or negative pressure compared to theatmospheric pressure may be in a range of 10 Pa to 30 000 Pa, or in arange of 100 Pa to 20 000 Pa or in a range of 0.5 kPa to 19 kPa or in arange of 1 kPa to 15 kPa.

Massage applied in order to improve body liquid flow and/or relaxationof the tissue in the deeper soft tissue layers may be applied withhigher pressure. Such positive or negative pressure may be in a rangefrom 12 kPa to 400 kPa or from 15 kPa to 300 kPa or from 20 kPa to 200kPa. An uncomfortable feeling of too high applied pressure may be usedto set a pressure threshold according to individual patient feedback.

Negative pressure may stimulate body liquid flow and/or relaxation ofthe deep soft tissue layers (0.5 cm to non-limited depth in the softtissue) and/or layers of the soft tissue near the patient surface (0.1mm to 0.5 cm). In order to increase effectiveness of the massagenegative pressure treatment may be used followed by positive pressuretreatment.

A number of suction openings changing pressure values on the patient'ssoft tissue in one pad 4 may be between 1 to 100 or between 1 to 80 orbetween 1 to 40 or between 1 to 10.

Sizes and/or shapes of suction openings may be different according totreated area. One suction opening may cover an area on the patientsurface between 0.1 mm² to 1 cm² or between 0.1 mm² to 50 mm² or between0.1 mm² to 40 mm² or between 0.1 mm² to 20 mm². Another suction openingmay cover an area on the patient surface between 1 cm² to 1 m² orbetween 1 cm² to 100 cm² or between 1 cm² to 50 cm² or between 1 cm² to40 cm².

Several suction openings may work simultaneously or switching betweenthem may be in intervals between 1 ms to 10 s or in intervals between 10ms to 5 s or in intervals between 0.5 s to 2 s.

Suction openings in order to provide massaging effect may be guidedaccording to one or more predetermined massage profile included in theone or more treatment protocols. The massage profile may be selected bythe operator and/or by a control unit (e.g. CPU) with regard to thepatient's condition. For example a patient with lymphedema may require adifferent level of compression profile and applied pressure than apatient with a healed leg ulcer.

Pressure applied by one or more suction openings may be graduallyapplied preferably in the positive direction of the lymph flow and/orthe blood flow in the veins. According to specific treatment protocolsthe pressure may be gradually applied in a direction opposite ordifferent from ordinary lymph flow. Values of applied pressure duringthe treatment may be varied according to the treatment protocol.

A pressure gradient may arise between individual suction openings.Examples of gradients described are not limited for this method and/ordevice. The setting of the pressure gradient between at least twoprevious and successive suction openings may be: 0%, i.e. The appliedpressure by suction openings is the same (e.g. pressure in all suctionopenings of the pad is the same);

1%, i.e. The applied pressure between a previous and a successivesuction opening decreases and/or increases with a gradient of 1% (e.g.the pressure in the first suction opening is 5 kPa and the pressure inthe successive suction opening is 4.95 kPa);

2%, i.e. The pressure decreases or increases with a gradient of 2%. Thepressure gradient between two suction openings may be in a range 0% to100% where 100% means that one suction openings is not active and/ordoes not apply any pressure on the patient's soft tissue.

A treatment protocol that controls the application of the pressuregradient between a previous and a successive suction opening may be in arange between 0.1% to 95%, or in a range between 0.1% to 70%, or in arange between 1% to 50%.

The suction opening may also comprise an impacting massage objectpowered by a piston, massage object operated by filling or sucking outliquid or air from the gap volume by an inlet/outlet valve or massageobject powered by an element that creates an electric field, magneticfield or electromagnetic field. Additionally, the massage may beprovided by impacting of multiple massage objects. The multiple massageobjects may have the same or different size, shape, weight or may becreated from the same or different materials. The massage objects may beaccelerated by air or liquid flowing (through the valve) or by anelectric, magnetic or electromagnetic field. Trajectory of the massageobjects may be random, circular, linear and/or massage objects mayrotate around one or more axes, and/or may do other types of moves inthe gap volume.

The massage unit may also comprise a membrane on the side facing thepatient which may be accelerated by an electric, magnetic,electromagnetic field or by changing pressure value in the gap volumebetween wall of the chamber and the membrane. This membrane may act asthe massage object.

During the treatment, it may be convenient to use a combination of padswith adhesive layer and pads with suction openings. In that case atleast one pad used during the treatment may comprise adhesive layer andat least additional one pad used during the treatment may comprisesuction opening. For example, pad with adhesive layer may be suited fortreatment of more uneven areas, e.g. periorbital area, and pad withsuction openings for treatment of smoother areas, e.g. cheeks.

The advantage of the device where the attachment of the pads may beprovided by an adhesion layer or by a suction opening or theircombination is that there is no need of any additional gripping systemwhich would be necessary to hold the pads on the treatment area duringthe treatment, e.g. a band or a felt, which may cause a discomfort ofthe patient.

In one aspect, the suction openings may provide the heated fluid tocause heating of the patient (e.g. hot air), which may be providedinstead of, or as u supplementary energy to the primary electromagneticenergy (e.g. radiofrequency energy).

Yet in another aspect, it is possible to fasten the flexible pads 4 tothe face by at least one fastening mechanism, for example—a band or afelt, which may be made from an elastic material and thus adjustable foran individual face. In that case the flexible pads, which may have notthe adhesive layer or suction opening, are placed on the treatment areaof the patient and their position is then fastened by a band or felt toavoid deflection of the pads from the treatment areas. Alternatively,the band may be replaced by a mask, e.g. an elastic mask that coversfrom 5% to 100% or from 30% to 99% or from 40% to 95% or from 50% to 90%of the face and may serve to secure the flexible pads on the treatmentareas. In another aspect, the mask may be rigid or semi rigid. The maskmay contain one connecting part comprising conductive leads which thendistributes the conductive leads to specific pads. Furthermore, it maybe possible to use the combination of the pad with adhesive layer orsuction opening and the fastening band, felt or mask to ensure strongattachment of the pads on the treatment areas.

Additionally, the fastening mechanism may be in the form of a textile ora garment which may be mountable on a patient's body part. In use of thedevice, a surface of the active element or pad 4 lays along an innersurface of the garment, while the opposite surface of the active elementor pad 4 is in contact with the patient's skin, preferably by means of askin-active element hydrogel interface.

The garment may be fastened for securement of the garment to or around apatient's body part, e.g. by hook and loop fastener, button, buckle,stud, leash or cord, magnetic-guided locking system or clamping band andthe garment may be manufactured with flexible materials or fabrics thatadapt to the shape of the patient's body or limb. The pad 4 may be inthe same way configured to be fastened to the inner surface of thegarment. The garment is preferably made of breathable materials. Nonlimiting examples of such materials are soft Neoprene, Nylon,polyurethane, polyester, polyamide, polypropylene, silicone, cotton orany other material which is soft and flexible. All named materials couldbe used as woven, non-woven, single use fabric or laminated structures.

The garment and the pad may be modular system, which means module orelement of the device (pad, garment) and/or system is designedseparately and independently from the rest of the modules or elements,at the same time that they are compatible with each other.

The pad 4 may be designed to be attached to or in contact with thegarment, thus being carried by the garment in a stationary or fixedcondition, in such a way that the pads are disposed on fixed positionsof the garment. The garment ensures the correct adhesion or dispositionof the pad to the patient's skin. In use of the device, the surface ofone or more active elements not in contact with the garment is incontact with the patient's skin, preferably by means of a hydrogel layerthat acts as pad-skin interface. Therefore, the active elements includedin the pad are in contact with the patient's skin.

The optimal placement of the pad on the patient's body part, andtherefore the garment which carries the pad having the active elements,is determined by a technician or clinician helping the patient.

In addition, the garment may comprise more than one pad or the patientmay wear more than one garment comprising one or more pads during onetreatment session.

The pad 4 contains at least one active element 13 capable of deliveringenergy from primary electromagnetic generator 6 or secondary generator 9or ultrasound emitter 10. In various aspects, the active element is anelectrode, an optical element, an acoustic window, an ultrasoundemitter, a coil, a fluid conduit, a heating element, or other energydelivering elements known in the art. The electrode may be aradiofrequency (RF) electrode. The RF electrode may be a dielectricelectrode coated with insulating (e.g. dielectric) material. The RFelectrode may be monopolar, bipolar, unipolar or multipolar. The bipolararrangement may consist of electrodes that alternate between active andreturn function and where the thermal gradient beneath electrodes isalmost the same during treatment. Bipolar electrodes may form circularor ellipsoidal shapes, where electrodes are concentric to each other.However, a group of bipolar electrode systems may be used as well. Aunipolar electrode or one or more multipolar electrodes may be used aswell. The system may alternatively use monopolar electrodes, where theso-called return electrode (or neutral electrode or ground electrode orgrounding electrode) has larger area than so-called active electrode.The thermal gradient beneath the active electrode is therefore higherthan beneath the return electrode. The active electrode may be part ofthe pad and the passive electrode having larger surface area may belocated at least 5 cm, 10 cm, or 20 cm from the pad. A neutral electrodemay be used as the passive electrode. The neutral electrode may be onthe opposite side of the patient's body than the pad is attached. Aunipolar electrode may also optionally be used. During unipolar energydelivery there is one electrode, no neutral electrode, and a large fieldof RF emitted in an omnidirectional field around a single electrode.Capacitive and/or resistive electrodes may be used. Radiofrequencyenergy may provide energy flux on the surface of the RF electrode or onthe surface of the treated tissue (e.g. skin) in the range of 0.001W/cm² to 1500 W/cm² or 0.01 W/cm² to 1000 W/cm² or 0.5 W/cm² to 500W/cm² or 0.5 W/cm² to 100 W/cm² or 1 W/cm² to 50 W/cm². The energy fluxon the surface of the RF electrode may be calculated from the size ofthe RF electrode and its output value of the energy. The energy flux onthe surface of the treated tissue may be calculated from the size of thetreated tissue exactly below the RF electrode and its input value of theenergy provided by the RF electrode. In addition, the RF electrodepositioned in the pad 4 may act as an acoustic window for ultrasoundenergy.

The active element 13 may provide a secondary energy from secondarygenerator 9 in the form of an electric current or a magnetic field. Byapplying the secondary energy to the treated area of the body of thepatient, muscle fibers stimulation (e.g. muscle contractions) may beachieved and thus increasing muscle tone, muscle strengthening,restoration of feeling the muscle, relaxation of the musculature and/orstretching musculature.

The magnetic field provided by the active element 13 (e.g. coil) usedfor simulation of the muscle may be in the range of 0.01 T to 7 T, or inthe range of 0.015 T to 4 T or in the range of 0.02 T to 1 T or in therange of 0.05 T to 0.5 T, on the surface of the active element (e.g.coil). The maximum value of the magnetic flux density derivative may bein the range of 1 T/s to 800 kT/s or in the range of 40 T/s to 320 kT/sor in the range of 80 T/s to 250 kT/s or in the range of 100 T/s to 250kT/s or in the range of 250 T/s to 180 kT/s or in the range of 500 T/sto 100 kT/s or in the range of 1 kT/s to 65 kT/s. The value of magneticflux density derivative may correspond to induced current within thetissue. The pulse duration of the magnetic field may be in the range of3 μs to 10 ms, or alternatively 3 μs to 3 ms or alternatively 3 μs to 1ms. The active element 13 (e.g. coil) may provide pulses of magneticfield with the frequency in the range of 1 Hz to 1200 kHz or in therange of 2 Hz to 600 Hz or in the range of 3 Hz to 250 Hz or in therange of 4 Hz to 150 Hz or in the range of 4 Hz to 65 Hz.

An inductance of the active element 13 (e.g. coil) used for magneticfield generation may be in the range of 1 nH to 500 mH, or in the rangeof 10 nH to 50 mH, or in the range of 50 nH to 10 mH, or in the range of500 nH to 1 mH, or in the range of 1 μH to 500 μH. Alternatively, theinductance of the active element (e.g. coil) used for magnetic fieldgeneration may be in the range of 1 nH to 100 μH, or in the range of 5nH to 50 μH, or in the range of 10 nH to 25 μH or in the range of 45 nHto 20 μH.

The proposed device may provide an electrotherapy in case that thesecondary energy delivered by the active element 13 (e.g anelectrotherapy electrode or simply referred just as an electrode, whichmay also be the radiofrequency electrode as described above) is theelectric current generated by the secondary generator 9. The maineffects of electrotherapy are: analgesic, myorelaxation, iontophoresis,anti-edematous effect or muscle stimulation causing a muscle fibercontraction. Each of these effects may be achieved by one or more typesof electrotherapy: galvanic current, pulse direct current andalternating current.

Galvanic current (or “continuous”) is a current that may have constantelectric current and/or absolute value of the electric current is inevery moment higher than 0. It may be used mostly for iontophoresis, orits trophic stimulation (hyperemic) effect is utilized. At the presentinvention this current may be often substituted by galvanic intermittentcurrent. Additionally, galvanic component may be about 95% but due tointerruption of the originally continuous intensity the frequency mayreach 5-12 kHz or 5-10 kHz or 5-9 kHz or 5-8 kHz.

The pulse direct current (DC) is of variable intensity but only onepolarity. The basic pulse shape may vary. It includes e.g. diadynamics,rectangular, triangular and exponential pulse of one polarity. Dependingon the used frequency and intensity it may have stimulatory, tropic,analgesic, myorelaxation, iontophoresis, at least partial musclecontraction and anti-edematous effect and/or other.

Alternating Current (AC or biphasic) where the basic pulse shape mayvary—rectangular, triangular, harmonic sinusoidal, exponential and/orother shapes and/or combination of mentioned above. It can bealternating, symmetric and/or asymmetric. Use of alternating currents incontact electrotherapy implies much lower stress on the tissue under theelectrode. For these types of currents the capacitive component of skinresistance is involved, and due to that these currents are very welltolerated by the patients.

AC therapies may be differentiated into five subtypes: TENS, Classic(four-pole) Interference, Two-pole Interference, Isoplanar Interferenceand Dipole Vector Field. There also exists some specific electrotherapyenergy variants and modularity of period, shape of the energy etc.

Due to interferential electrotherapy, different nerves and tissuestructures by medium frequency may be stimulated in a range of 500 Hz to12 kHz or in a range of 500 Hz to 8 kHz, or 500 Hz to 6 kHz, creatingpulse envelopes with frequencies for stimulation of the nerves andtissues e.g. sympathetic nerves (0.1-5 Hz), parasympathetic nerves(10-150 Hz), motor nerves (10-50 Hz), smooth muscle (0.1-10 Hz), sensornerves (90-100 Hz) nociceptive fibers (90-150 Hz).

Electrotherapy may provide stimulus with currents of frequency in therange from 0.1 Hz to 12 kHz or in the range from 0.1 Hz to 8 kHz or inthe range from 0.1 Hz to 6 kHz.

Muscle fiber stimulation by electrotherapy may be important duringand/or as a part of the RF treatment. Muscle stimulation increases bloodflow and lymph circulation. It may improve removing of treated cellsand/or prevent of hot spots creation. Moreover internal massagestimulation of adjoining tissues improves homogeneity of tissue anddispersing of the delivered energy. The muscle fiber stimulation byelectrotherapy may cause muscle contractions, which may lead toimprovement of a visual appearance of the patient through muscle firmingand strenghtening, Another beneficial effect is for example during fatremoving with the RF therapy. RF therapy may change structure of the fattissue. The muscle fiber stimulation may provide internal massage, whichmay be for obese patient more effective than classical massage.

Muscle stimulation may be provided by e.g. intermittent direct currents,alternating currents (e.g. medium-frequency currents, Russian currentsand TENS currents), faradic current as a method for multiple stimulationand/or others.

Frequency of the currents may be in the range from 0.1 Hz to 1500 Hz orfrom 0.1 to 1000 Hz or from 0.1 Hz to 500 Hz or from 0.1 to 300 Hz.

Frequency of the current envelope is typically in the range from 0.1 Hzto 500 Hz or from 0.1 to 250 Hz or from 0.1 Hz to 150 Hz or from 0.1 to140 Hz. Additionally, the current envelopes may have an enveloperepetition frequency (ERF) in a range of 0.01 to 100 per second, or of0.05 to 50 per second, or of 0.07 to 30 per second, or of 0.1 to 20 persecond, or of 0.2 to 6 per second.

The electrostimulation may be provided in a combined manner wherevarious treatments with various effects may be achieved. As anillustrative example, the electromagnetic energy with theelectrostimulation may be dosed in trains of pulses of electric currentwhere the first train of electrostimulation may achieve different effectthan second or other successive train of stimulation. Therefore, thetreatment may provide muscle fibers stimulation or muscle contractionsfollowed by relaxation, during continual or pulsed radiofrequencythermal heating provided by electromagnetic energy provided byelectromagnetic energy generator.

The electrostimulation may be provided by monopolar, unipolar, bipolaror multipolar mode.

Absolute value of voltage between the electrotherapy electrodes operatedin bipolar, multipolar mode (electric current flow between more than twoelectrodes) and/or provided to at least one electrotherapy electrode maybe in a range between 0.8 V and 10 kV; or in a range between 1 V and 1kV; or in a range between 1 V and 300 V or in a range between 1 V and100 V or in a range between 10 V and 80 V or in a range between 20 V and60 V or in a range between 30 V and 50 V.

Current density of electrotherapy for a non-galvanic current may be in arange between 0.1 mA/cm² and 150 mA/cm², or in a range between 0.1mA/cm² and 100 mA/cm², or in a range between 0.1 mA/cm² and 50 mA/cm²,or in a range between 0.1 mA/cm² and 20 mA/cm²; for a galvanic currentmay be preferably in a range between 0.05 mA/cm² and 3 mA/cm², or in arange between 0.1 mA/cm² and 1 mA/cm², or in a range between 0.01 mA/cm²and 0.5 mA/cm². The current density may be calculated on the surface ofthe electrode providing the electrotherapy to the patient. In oneaspect, the current density of electrotherapy for a non-galvanic currentmay be in a range between 0.1 mA/cm² and 200 mA/cm², or in a rangebetween 0.5 mA/cm² and 150 mA/cm², or in a range between 1 mA/cm² and120 mA/cm², or in a range between 5 mA/cm² and 100 mA/cm².

The electric current in one pulse in case of a pulsed electric current(e.g. pulse mode) may be in the range of 0.5 mA to 150 mA, in the rangeof 1 mA to 100 mA, in the range of 5 mA to 75 mA, or in the range of 10mA to 55 mA. The duration of one electric current pulse may bepreferably in the range of 1 to 500 μs, in the range of 10 to 350 μs, inthe range of 20 to 200 μs, in the range of 35 to 150 μs, or in the rangeof 50 to 100 μs.

During electrotherapy, e.g. bipolar electrotherapy, two or moreelectrodes may be used. If polarity of at least one electrode has anon-zero value in a group of the electrodes during bipolar mode, thegroup of the electrodes has to include at least one electrode withopposite polarity value. Absolute values of both electrode polaritiesmay or may not be equal. In bipolar electrostimulation mode stimulatingsignal passes through the tissue between electrodes with oppositepolarities.

A distance between two electrodes operating in bipolar mode may be in arange between 0.1 mm and 4 cm or in a range between 0.2 mm to 3 cm or ina range between 0.5 mm and 2 cm or in a range between 1 mm and 1 cm orin a range between 2 mm and 7 mm, or in the range of 0.1 cm and 40 cm orin a range between 1 cm and 30 cm, or in the range between 1 cm and 20cm, wherein the distance is between the two closest points of twoelectrodes operating in bipolar mode.

During monopolar electrotherapy mode stimulating signal may be inducedby excitement of action potential by changing polarity of one electrodethat change polarization in the nerve fiber and/or neuromuscular plague.

During the electrotherapy, one of the bipolar or monopolarelectrotherapy mode may be used or bipolar or monopolar electrotherapymode may be combined.

The ultrasound emitters may provide focused or defocused ultrasoundenergy. The ultrasound energy may be transferred to the tissue throughan acoustic window. The output power of the ultrasound energy on thesurface of the active element 13 may be less than or equal to 20 W or 15W or 10 W or 5 W. Ultrasound energy may provide energy flux on thesurface of the active element 13 or on the surface of the treated tissue(e.g. skin) in the range of 0.001 W/cm² to 250 W/cm², or in the range of0.005 W/cm² to 50 W/cm², or in the range of 0.01 W/cm² to 25 W/cm², orin the range of 0.05 W/cm² to 20 W/cm². The treatment depth ofultrasound energy may be in the range of 0.1 mm to 100 mm or 0.2 mm to50 mm or 0.25 mm to 25 mm or 0.3 mm to 15 mm. At a depth of 5 mm theultrasound energy may provide an energy flux in the range of 0.01 W/cm²to 20 W/cm² or 0.05 W/cm² to 15 W/cm². An ultrasound beam may have abeam non-uniformity ratio (R_(BN)) in the range of 0.1 to 20 or 2 to 15to 4 to 10. In addition, an ultrasound beam may have a beamnon-uniformity ratio below 15 or below 10. An ultrasound beam may bedivergent, convergent and/or collimated. The ultrasound energy may betransferred to the tissue through an acoustic window. It is possiblethat the electrode may act as the acoustic window. Furthermore, theultrasound emitter 10 may be a part of the active element 13, thusultrasound emitter 10 may be a part of the pad 4.

In one aspect, the ultrasound may provide heating of the patient, andthe ultrasound emitter 10 may be used instead of the primaryelectromagnetic generator 6, which may not be presented in the device.In another aspect, the ultrasound may provide supplementary heatingenergy to the energy generated by the primary electromagnetic generator6.

At least some of the active elements 13 may be capable of deliveringenergy from primary electromagnetic generator 6 or secondary generator 9or ultrasound emitter 10 simultaneously (at the same time) successivelyor in an overlapping method or in any combination thereof. For example,the active element 13 (e.g. electrode) may be capable of deliveringradiofrequency energy and electric current sequentially, which may meanthat firstly the active element 13 may provide primary electromagneticenergy generated by the primary electromagnetic generator 6 andsubsequently the active element 13 may provide the secondary energygenerated by the secondary generator 9. Thus the active element 13 maye.g. apply radiofrequency energy to the tissue of the patient and thenthe same active element 13 may apply e.g. electrical current to thetissue of the patient. In one aspect, the primary electromagneticgenerator may generate both, the radiofrequency energy and the electriccurrent.

In one aspect, the proposed device 1 may provide only one treatmentenergy, e.g. only electric current to cause a muscle stimulation or onlyradiofrequency energy to cause heating of the tissue.

The active element (e.g. electrode or coil) may be cooled. A coolingmember may provide cooling by any known mechanism including e.g. watercooling, sprayed coolant, presence of an active solid cooling element(e.g. thermoelectric cooler), or air flow cooling. Cooling of the activeelement (e.g. electrode or coil) may be provided during, before, orafter the active element provides an energy to the patient. Thetemperature of the cooling member may be in the range of −80° C. to 36°C., in the range of −70° C. to 35° C., in the range of −60° C. to 34°C., in the range of −20° C. to 30° C., in the range of 0° C. to 27° C.,in the range of 5° C. to 25° C.

Pad 4 may further comprise thermal sensors 15 enabling temperaturecontrol during the therapy, providing feedback to control unit (e.g.CPU) 11, enabling adjustment of treatment parameters of each activeelement and providing information to the operator. The thermal sensor 15may be a contact sensor, contactless sensor (e.g. infrared temperaturesensor) or invasive sensor (e.g. a thermocouple) for precise temperaturemeasurement of deep layers of skin, e.g. epidermis, dermis orhypodermis. The control unit (e.g. CPU) 11 may also use algorithms tocalculate the deep or upper-most temperatures. A temperature feedbacksystem may control the temperature and based on set or pre-set limitsalert the operator in human perceptible form, e.g. on the human machineinterface 8 or via indicators 17. In a limit temperature condition, thedevice may be configured to adjust one or more treatment parameters,e.g. output power, switching mode, pulse length, etc. or stop thetreatment. A human perceptible alert may be a sound, alert message shownon human machine interface 8 or indicators 17 or change of color of anypart of the interconnecting block 3 or pad 4.

The pad may comprise at least one electromyography (EMG) sensingelectrode configured to monitor, to record or to evaluate the electricalactivity produced by skeletal muscles (e.g. twitch or contraction) inresponse to delivered energy (e.g. electric current). The at least oneEMG sensing electrode being disposed on the pad may be electricallyinsulated from the active elements (e.g. electrodes used for treatment).An electromyograph detects the electric potential generated by musclecells when these cells are electrically or neurologically activated. Thesignals can be analyzed to detect abnormalities, activation level, orrecruitment order, or to analyze the biomechanics of the patient'smovement. The EMG may be one of a surface EMG or an intramuscular EMG.The surface EMG can be recorded by a pair of electrodes or by a morecomplex array of multiple electrodes. EMG recordings display thepotential difference (voltage difference) between two separateelectrodes. Alternatively the active elements, e.g. electrodes, may beused for EMG, for example when the active element is not active (e.g.does not provide/deliver any type of energy/signal to the patient) itmay be used for EMG detection/recording. The intramuscular EMG may berecorded by one (monopolar) or more needle electrodes. This may be afine wire inserted into a muscle with a surface electrode as areference; or more fine wires inserted into muscle referenced to eachother. Muscle tissue at rest is normally electrically inactive. Afterthe electrical activity caused by delivered energy (e.g. electriccurrent), action potentials begin to appear. As the strength of a musclecontraction is increased, more and more muscle fibers produce actionpotentials. When the muscle is fully contracted, a disorderly group ofaction potentials of varying rates and amplitudes should appear (acomplete recruitment and interference pattern).

The pad may also comprise at least one capacitive sensor for measurementof the proper contact of the pad with the patient. The capacitive sensormay be connected to at least two complementary metal-oxide-semiconductor(CMOS) integrated circuit (IC) chips, an application-specific integratedcircuit (ASIC) controller and a digital signal processor (DSP) which maybe part of the control unit. The capacitive sensor may detect andmeasure the skin based on the different dielectric properties than theair, thus when the pad is detached from the patient a change in thesignal may be detected and further processed by the control unit. Thecapacitance sensor may be configured in a surface capacitance or in aprojected capacitance configuration. For better information about thecontact and for higher safety, a single pad may comprise 3 to 30 or 4 to20 or 5 to 18 or 6 to 16 or 7 to 14 capacitance sensors.

Memory 12 may include, for example, information about the type and shapeof the pad 4, its remaining lifetime, or the time of therapy that hasalready been performed with the pad. The memory may also provideinformation about the manufacturer of the pad or information about thedesignated area of use on the body of the patient. The memory mayinclude RFID, MRAM, resistors, or pins.

Neutral electrode 7 may ensure proper radiofrequency energy distributionwithin the patient's body for mono-polar radiofrequency systems. Theneutral electrode 7 is attached to the patient's skin prior to eachtherapy so that the energy may be distributed between active element 13(e.g. electrode) and neutral electrode 7. In some bipolar or multipolarradiofrequency systems, there is no need to use a neutralelectrode—because radiofrequency energy is distributed between multipleactive elements 13 (e.g. electrodes). Neutral electrode 7 represents anoptional block of the apparatus 1 as any type of radiofrequency systemcan be integrated. In one aspect, the neutral electrode 7 may be part ofthe pad 4.

Additionally, device 1 may include one or more sensors. The sensor mayprovide information about at least one physical quantity and itsmeasurement may lead to feedback which may be displayed by human machineinterface 8 or indicators 17. The one or more sensors may be used forsensing delivered electromagnetic energy, impedance of the skin,resistance of the skin, temperature of the treated skin, temperature ofthe untreated skin, temperature of at least one layer of the skin, watercontent of the device, the phase angle of delivered or reflected energy,the position of the active elements 13, the position of theinterconnecting block 3, temperature of the cooling media, temperatureof the primary electromagnetic generator 6 and secondary generator 9 andultrasound emitter 10 or the contact with the skin. The sensor may be athermal, acoustic, vibration, electric, magnetic, flow, positional,optical, imaging, pressure, force, energy flux, impedance, current, Hallor proximity sensor. The sensor may be a capacitive displacement sensor,acoustic proximity sensor, gyroscope, accelerometer, magnetometer,infrared camera or thermographic camera. The sensor may be invasive orcontactless. The sensor may be located on or in the pad 4, in the mainunit 2, in the interconnecting block 3 or may be a part of a thermalsensor 15. One sensor may measure more than one physical quantity. Forexample, the sensor may include a combination of a gyroscope, anaccelerometer and/or a magnetometer. Additionally, the sensor maymeasure one or more physical quantities of the treated skin or untreatedskin.

A resistance sensor may measure skin resistance, because skin resistancemay vary for different patients, as well as the humidity—wetness andsweat may influence the resistance and therefore the behavior of theskin in the energy field. Based on the measured skin resistance, theskin impedance may also be calculated.

Information from one or more sensors may be used for generation of apathway on a model e.g. a model of the human body shown on a display ofhuman machine interface 8. The pathway may illustrate a surface orvolume of already treated tissue, presently treated tissue, tissue to betreated, or untreated tissue. A model may show a temperature map of thetreated tissue providing information about the already treated tissue oruntreated tissue.

The sensor may provide information about the location of bones, inflamedtissue or joints. Such types of tissue may not be targeted byelectromagnetic energy due to the possibility of painful treatment.Bones, joints or inflamed tissue may be detected by any type of sensorsuch as an imaging sensor (ultrasound sensor, IR sensor), impedancesensor, and the like. A detected presence of these tissue types maycause general human perceptible signals or interruption of generation ofelectromagnetic energy. Bones may be detected by a change of impedanceof the tissue or by analysis of reflected electromagnetic energy.

In one aspect the active elements 13, may be used as the sensorsdescribed above. For example, the active element 13 (e.g. electrode) maymeasure impedance before, during or after providing the radiofrequencyenergy. In addition, the active element 13 (e.g. electrode) may measurethe voltage or the current passing through the patient during theelectric current stimulation. Based on those information it may bepossible to determine proper contact of the pad 4 or active elements 13(e.g. electrodes) with the patient.

The patient's skin over at least one treatment portion may be pre-cooledto a selected temperature for a selected duration, the selectedtemperature and duration for pre-cooling may be sufficient to cool theskin to at least a selected temperature below normal body temperature.The skin may be cooled to at least the selected temperature to a depthbelow the at least one depth for the treatment portions so that the atleast one treatment portion is substantially surrounded by cooled skin.The cooling may continue during the application of energy, and theduration of the application of energy may be greater than the thermalrelaxation time of the treatment portions. Cooling may be provided byany known mechanism including water cooling, sprayed coolant, presenceof an active solid cooling element (e.g. thermoelectric cooler) or airflow cooling. A cooling element may act as an optical element.Alternatively, the cooling element may be a spacer. Cooling may beprovided during, before or after the treatment with electromagneticenergy. Cooling before treatment may also provide an environment forsudden heat shock, while cooling after treatment may provide fasterregeneration after heat shock. The temperature of the coolant may be inthe range of −200° C. to 36° C. The temperature of the cooling elementduring the treatment may be in the range of −80° C. to 36° C. or −70° C.to 35° C. or −60° C. to 34° C. or −20° C. to 30° C. or 0° C. to 27° C.or 5° C. to 25° C. Further, where the pad is not in contact with thepatient's skin, cryogenic spray cooling, gas flow or other non-contactcooling techniques may be utilized. A cooling gel on the skin surfacemight also be utilized, either in addition to or instead of, one of thecooling techniques indicated above.

FIG. 3A and FIG. 3B show different shapes and layouts of pad 4 used byan apparatus for contact therapy. Pads 4 comprise at least one activeelement 13 (e.g. electrode) and may be available in various shapes andlayouts so that they may cover a variety of different treatment areasand accommodate individual patient needs, e.g. annular, semicircular,elliptical, oblong, square, rectangular, trapezoidal, polygonal orformless (having no regular form or shape). The shapes and layouts ofthe pad 4 may be shaped to cover at least part of one or more of theperiorbital area, the forehead (including frown lines), the jaw line,the perioral area (including Marionette lines, perioral lines—so calledsmoker lines, nasolabial folds, lips and chin), cheeks or submentum,etc. The shape of the pad 4 and distribution, size and number of activeelements 13 (e.g. electrodes) may differ depending on the area beingtreated, e.g. active elements 13 inside the pad 4 may be in one line,two lines, three lines, four lines or multiple lines. The pad 4 withactive elements 13 may be arranged into various shapes, e.g. in a line,where the centers of at least two active elements 13 lie in one straightline, while any additional center of an active element 13 may lie in thesame or different lines inside the pad 4.

In addition, the pad 4 may be used to treat at least partially neck, brafat, love handles, torso, back, abdomen, buttocks, thighs, calves, legs,arms, forearms, hands, fingers or body cavities (e.g. vagina, anus,mouth, inner ear etc.).

The pad 4 may have a rectangular, oblong, square, trapezoidal form, orof the form of a convex or concave polygon wherein the pad 4 may have atleast two different inner angles of the convex or concave polygonstructure. Additionally, the pad 4 may form at least in part the shapeof a conic section (also called conic), e.g. circle, ellipse, parabolaor hyperbola. The pad 4 may have at least in part one, two, three, four,five or more curvatures of a shape of an arc with the curvature kin therange of 0.002 to 10 mm⁻¹ or in the range of 0.004 to 5 mm⁻¹ or in therange of 0.005 to 3 mm⁻¹ or in the range of 0.006 to 2 mm⁻¹. The pad 4may have at least one, two, three, four, five or more arcs with thecurvature k or may have at least two different inner angles of a convexor concave polygon structure, and may be suitable for the treatment ofchin, cheeks, submental area (e.g. “banana shape 1” 4.2), for treatingjaw line, perioral area, Marionette lines and nasolabial folds (e.g.“banana shape 2” 4.4), for the treatment of periorbital area (e.g.“horseshoe shape” 4.3) or other regions of face and neck. The “bananashape” pad 4.2 or 4.4 may have a convex-concave shape, which means thatone side is convex and the opposite side is concave, that occupies atleast 5% to 50% or 10% to 60% or 15% to 70% or 20% to 90% of a totalcircumference of the pad 4 seen from above, wherein the shortestdistance between the endpoints 4.21 a and 4.21 b of the “banana shape”pad 4.2 (dashed line in FIG. 3A) is longer than the shortest distancebetween the endpoint 4.21 a or 4.21 b and the middle point 4.22 of the“banana shape” (full line in pad 4.2 in FIG. 3A). The “horseshoe shape”4.3 seen from above may have the convex-concave shape that occupies atleast 15% to 50% or 20% to 60% or 25% to 70% or 30% to 90% of its totalcircumference, wherein the shortest distance between the endpoints 4.31a and 4.31 b of the “horseshoe shape” pad 4.3 (dashed line in FIG. 3B)is equal or shorter than the shortest distance between the endpoint 4.31a or 4.31 b and the middle point 4.32 of the “horseshoe shape” (fullline in pad 4.3 in FIG. 3B). When seen from above, if the longestpossible center curve, which may be convex or concave and whoseperpendiculars at a given point have equidistant distance from perimeteredges of the pad at each of its points (dotted line in pad 4.2 in FIG.3A), intersects the circumference of the pad 4 then this point is theendpoint of the pad, e.g. endpoint 4.21 a or 4.21 b. The middle point,e.g. 4.22, is then given as the middle of the center curve, wherein thetotal length of the center curve is given by two endpoints, e.g. 4.21 aand 4.21 b, thus the length of the center curve (dotted line in pad 4.2in FIG. 3A) from point 4.21 a to point 4.22 is the same as the lengthfrom point 4.21 b to point 4.22. The total length of the center curvemay be in the range of 0.1 to 30 cm or in the range of 0.5 to 25 cm orin the range of 1 to 20 cm.

In addition, the center curve may have at least in part circular,elliptical, parabolic, hyperbolic, exponential, convex or concave curvesuch that the straight line connecting endpoint of the pad 4 with themiddle point of the center curve forms an angle alpha with the tangentof the middle of the center curve. The angle alpha may be in a range of0.1° to 179° or in a range of 0.2° to 170° or in a range of 0.5° to 160°or in a range of 1° to 150°.

The pad 4 whose shape has at least two concave arcs with the curvature kor has at least two concave inner angles of the polygon structure may besuitable for the treatment of the forehead like the “T shape” 4.1 inFIG. 3A. The “T shape” 4.1 may be also characterized by the arrangementof the active elements 13 where the centers of at least two activeelements 13 lie in one straight line and center of at least oneadditional element 13 lies in a different line.

Another possible non-limiting configuration of the pad 4 used for thetreatment of the forehead is depicted in FIG. 3C. In this non-limitingexample, a forehead pad (pad 4 used for threatment of the forehead) mycontain two lines of active elements 13 (e.g. electrodes)—activeelements 13 a-13 f as shown in FIG. 3C, wherein the active elements 13a-13 f in one line may be at least partially separated by slots 43 forbetter flexibility of the pad 4. A first line of active elementscomprises active elements (e.g. electrodes) depicted in the dotted box131 a in FIG. 3C—active elements 13 d, 13 e and 13 f. The second line ofactive elements (e.g. electrodes) comprises active elements depicted inthe dashed box 131 b in FIG. 3C—active elements 13 a, 13 b, 13 c. Dottedand dashed boxes 131 a and 131 b are used only for visualization of thefirst and second lines of active elements (e.g. electrodes),respectively. Such pad 4 may have a shape that has a total number ofconvex and/or concave arcs in a range of 14 to 36 or in a range of 18 to32 or in a range of 20 to 30 or in a range of 22 to 28 with a curvaturek. Additionally, the pad 4 may have a number of concave inner angles ina range of 2 to 20 or in a range of 5 to 17 or in a range of 7 to 15 orin a range of 9 to 13, or the pad 4 may have a number of convex innerangles in a range of 2 to 20 or in a range of 5 to 17 or in a range of10 to 16 or in a range of 11 to 15.

FIG. 3C also shows the sticker 44 on a top side of the pad 4. The topside is the opposite side from the underside (the side where theadhesive layer or the active elements may be deposited on the substrateof the pad 4) or in other words, the top side is the side of the pad 4that is facing away from the patient during the treatment. The sticker44 may have a bottom side and a top side, wherein the bottom side of thesticker 44 may comprise a sticking layer and the top side of the sticker44 may comprise a non-sticking layer (eg. polyimide (PI) films, PTFE(e.g. Teflon®), epoxy, polyethylene terephthalate (PET), polyamide or PEfoam).

As shown in FIG. 3C, the sticker 44 may have the same or similar shapeas the pad 4 with an additional overlap over the pad 4. The overlap ishatched in FIG. 3C. The sticker 44 may be bonded to the pad 4 such thatthe sticking layer of the bottom side of the sticker 44 is facing towardthe top side of the pad 4. The overlap of the sticker may exceed the pad4 in the range of 0.1 to 10 cm, or in the range of 0.1 to 7 cm, or inthe range of 0.2 to 5 cm, or in the range of 0.2 to 3 cm, or in therange of 0.3 to 1 cm. This overlap may also comprise an adhesive layerand may be used to form additional and more proper contact of the pad 4with the patient. In another aspect, the sticker may have differentshapes or sizes than the pad.

The forehead pad (pad 4 used for treatment of the forehead) may compriseedge active elements (e.g. electrodes) 13 a, 13 c, 13 d and 13 f andmiddle active elements (e.g. electrodes)—13 b and 13 e as shown in FIG.3C. The forehead pad 4 may be divided into an upper side 131 a withactive elements (e.g. electrodes) 13 d, 13 e, and 13 f, and bottom side131 b with active elements (e.g. electrodes) 13 a, 13 b, and 13 c, aswell as a left side with active elements (e.g. electrodes) 13 a and 13f, and a right side with active elements (e.g. electrodes) 13 c and 13d. Edge active elements (e.g. electrodes) 13 a, 13 c, 13 d and 13 f inthe forehead pad 4 depicted in FIG. 3C may have a surface area in therange of 1 to 10 cm² or in the range of 2 to 6.5 cm² or in the range of2.3 to 6 cm² or in the range of 2.5 to 5.5 cm², which may be the samefor all edge active elements. The middle active elements (e.g.electrodes) 13 b and 13 e in FIG. 3C may have a same surface area as theedge active elements (e.g. electrodes) or may have a larger surface areathan the edge active elements (e.g. electrodes), wherein the surfacearea of the middle active elements (e.g. electrodes) may be in the rangeof 1 to 20 cm² or in the range of 2 to 15 cm² or in the range of 3 to 12cm² or in the range of 4 to 10 cm². In one aspect, each active element(e.g. electrode) may have a different surface area. The ratio of asurface area of one middle active element (e.g. electrode) to a surfacearea of one edge active element (e.g. electrode) on the forehead pad maybe in a range of 0.8 to 2.5 or in a range of 1 to 2.3 or in a range of1.1 to 2.2.

The distance d_(edge) between the closest points of the bottom edgeactive elements (e.g. electrodes) 13 a and 13 c in the FIG. 3C or theupper edge active elements (e.g. electrodes) 13 d and 13 f in the FIG.3C may be in the range of 2 to 8 cm or in the range of 3 to 7 cm or inthe range of 4 to 6 cm or in the range of 4.5 to 5.5 cm. The distanced_(edge) between the upper edge active elements (e.g. electrodes) andthe distance d_(edge) between the bottom edge active elements (e.g.electrodes) may be the same.

The distance d_(vert) between the closest points of the upper activeelements (e.g. electrodes) and the bottom active elements (e.g.electrodes) on one side (left, middle, right), e.g. the distance betweenactive elements 13 a and 13 f, between active elements 13 b and 13 e, orbetween active elements 13 c and 13 d in FIG. 3C may be in the range of0.5 to 20 mm or in the range of 1 to 10 mm or in the range of 1.5 to 6mm or in the range of 2 to 5 mm. The distance d_(vert) may be the samefor the left, middle and right active elements.

Such distances (d_(edge) and d_(vert)) are optimized to mitigate theedge effects (e.g. prevent creation of hot spots near edges) or leakagecurrents and effectively treat, e.g. the Frontalis muscle or Procerusmuscle during the treatment. The edge active elements (e.g.electrodes)—13 a, 13 c, 13 d and 13 f in FIG. 3C are used for treatmentof Frontalis muscle and/or Corrugator supercilii and the middle activeelements (e.g. electrodes)—13 b and 13 e in FIG. 3C are used fortreatment of Procerus muscle.

The forehead pad (pad 4 used for treatment of the forehead) in FIG. 3Calso shows a possible arrangement of the bottom middle part of the pad 4comprising the bottom middle active element (e.g. electrode)13 b. Thepad 4 may comprise a convex protrusion 4 p and/or concave depression inthe bottom middle part. Also the active element 13 b may be designed ina shape proximate to an oblong or rectangular shape with a convexprotrusion 13 p and/or concave depression in the middle of the bottompart of the active element 13 b copying a shape of the pad 4 with theprotrusion 4 p and/or depression of the pad. This protrusion 4 p and/ordepression may serve as a focus point for a correct coupling of the pad4 to the forehead area of the patient, wherein the protrusion 4 p and/ordepression should be aligned with the middle of the nose of the patient(e.g. in the middle of Procerus muscle) and at the same time the bottomedge of the pad 4 should be coupled slightly over the eyebrows of thepatient.

One possible non-limiting configuration of the pad 4 used for thetreatment of the left cheek is depicted in FIG. 3D. In this non-limitingexample, middle active elements (e.g. electrodes)—active elements 13 g,13 h, 13 i and 13 j may be separated on the substrate and the distanced_(mid) between the closest points of two neighboring middle activeelements (e.g. electrodes) may be in the range of 0.5 to 5 mm or in therange of 0.8 to 3 mm or in the range of 1 to 2.5 mm or in the range of1.2 to 2.3 mm. The left cheek pad (the pad 4 used for the treatment ofthe left cheek) depicted in FIG. 3D may be designed to be coupled to thepatient such that the bottom of the pad 4 is aligned and slightly abovethe left part of the base of the mandible, represented by the number 301in FIG. 3D. The middle active elements (e.g. electrodes) 13 g, 13 h, 13i and 13 j in FIG. 3D may have a surface area in the range of 1 to 15cm² or in the range of 2 to 8 cm² or in the range of 2.5 to 6 cm² or inthe range of 3 to 5 cm². The edge active elements (e.g. electrodes) 13k, 13 l and 13 m may have a surface area in the range of 1 to 20 cm² orin the range of 2 to 10 cm² or in the range of 2.5 to 8 cm² or in therange of 3.5 to 7 cm². The ratio of a surface area of the edge activeelement (e.g. electrode)—one of 13 k, 13 l or 13 m, to a surface area ofthe middle active element (e.g. electrode)—one of 13 g, 13 h, 13 i or 13j in FIG. 3D, may be in a range of 0.5 to 3 or in a range of 0.8 to 2.5or in a range of 1 to 2 or in a range of 1 to 1.8.

The middle active elements (e.g. electrodes) 13 g, 13 h, 13 i and 13 jin FIG. 3D are optimally configured to mitigate the edge effects (e.g.prevent creation of hot spots near edges) or leakage currents and totreat e.g. the Buccinator, Risorius, Zygomaticus and/or Masseter muscle.The middle active elements (e.g. electrodes) 13 g, 13 h, 13 i and 13 jin FIG. 3D are optimally configured to treat e.g. the Platysma,Depressor and/or Lavator labii superioris muscles. The number of themiddle active elements (e.g. electrodes) may be in the range of 1 to 10,in the range of 1 to 8, in the range of 2 to 6, or in the range of 2 to4. The number of the edge active elements (e.g. electrodes) may be inthe range of 1 to 10, in the range of 1 to 7, in the range of 1 to 6, orin the range of 2 to 5.

The pad 4 used for the treatment of the right cheek may be symmetricallyarranged to the left cheek pad 4 depicted in FIG. 3D.

In one aspect, the cheek pad 4 may be symmetrical as depicted in FIG.3E. Such symmetrical cheek pad may be used for left cheek or right cheektreatment. The symmetry is along the axis 333 (dashed line in FIG. 3E).A first line of active elements (e.g. electrodes) 13 n 1, 13 o 1 and 13p 1 are above the axis 333 and the symmetrical second line of activeelements (e.g. electrodes) 13 n 2, 13 o 2 and 13 p 2 are under the axis333. Thus, the symmetrical cheek pad may have pair active elements (e.g.electrodes)—e.g. 13 n 1 and 13 n 2, 13 o 1 and 13 o 2, or 13 p 1 and 13p 2, wherein the active elements (e.g. electrodes) in each pair have thesame shape symmetrical to the axis 333. The area of the active elements(e.g. electrodes) may be the same or different for each active element(e.g. electrodes). In one aspect all active elements (e.g. electrodes)13 n 1-13 p 2 may have the same surface area, wherein the surface are ofone active element (e.g. electrode) is in the range of 1 to 15 cm², inthe range of 2 to 8 cm², in the range of 2.5 to 6 cm², or in the rangeof 3 to 5 cm². In another aspect, the surface area of active elements(e.g. electrodes) 13 n 1-13 p 2 may be different for each active element(e.g. electrode) or a pair active elements (e.g. pair 13 n 1 and 13 n 2)may have the same surface area which is different than a surface area ofother pair active elements (e.g. pair 13 p 1 and 13 p 2), wherein thesurface area of one active element (e.g. electrode) may be in the rangeof 1 to 20 cm², in the range of 2 to 10 cm², or in the range of 2.5 to 8cm², or in the range of 3.5 to 7 cm².

Inter-active elements distance d_(intr) depicted in FIG. 3E is adistance between two closest points of neighboring active elements (e.g.electrodes), e.g. active element 13 o 1 and active element 13 p 1.Inter-active elements distance d_(intr) may be in in the range of 0.5 to5 mm, in the range of 0.8 to 4 mm, in the range of 1 to 3.3 mm, or inthe range of 1.2 to 2.8 mm. The active elements (e.g. electrodes) 13 n1-13 p 2 in FIG. 3E are optimally configured to mitigate the edgeeffects (e.g. prevent creation of hot spots near edges) or leakagecurrents and to treat the e.g. Buccinator, Risorius, Zygomaticus,Masseter, Platysma, Depressor and/or Lavator labii superioris muscles.

Another possible non-limiting configuration of the pad 4, which may beused for treatment of the forehead, is shown in FIG. 3F. The pad 4 mayhave a pair of left edge active elements (e.g. electrodes) 13 q 1 and 13q 2, and a pair of right edge active elements (e.g. electrodes) 13 s 1and 13 s 2. The left edge active elements (e.g. electrodes) 13 q 1 and13 q 2, may be symmetrical along at least one axis, e.g. the horizontalaxis 332 in FIG. 3F. The right edge active elements (e.g. electrodes) 13s 1 and 13 s 2, may be symmetrical along at least one axis, e.g. thehorizontal axis 332 in FIG. 3F. The pad 4 may have a pair of middleactive elements (e.g. electrodes) 13 r 1 and 13 r 2 which may besymmetrical along the horizontal axis 332, or may be not symmetricalalong the horizontal axis 332 but may be symmetrical along the verticalaxis 334. In fact, the whole layout of the active elements (e.g.electrodes) on the pad 4 may be symmetrical along at least one axis,e.g. the vertical axis 334 in FIG. 3F.

The active elements (e.g. electrodes) may have the same or differentsurface area, or pair active elements (e.g. active elements 13 q 1 and13 q 2) may have the same surface area, which may be different than thesurface area of another pair of active elements (e.g. active elements 13r 1 and 13 r 2). The surface area of the active element (e.g. electrode)is in the range of 1 to 10 cm2 or in the range of 2 to 6.5 cm2 or in therange of 2.3 to 6 cm2 or in the range of 2.5 to 5.5 cm2. The activeelements (e.g. electrodes) may have the distances d_(edge) and d_(vert)between them as described above, which are optimized to mitigate theedge effects (e.g. prevent creation of hot spots near edges) or leakagecurrents and effectively treat e.g. the Frontalis muscle or Procerusmuscle during the treatment. Some active elements (e.g. electrodes) maybe also at least partially separated by the slots 43 of the pad, e.g.active elements 13 r 2 and 13 s 2 for better coupling of the pad 4 withthe patient.

All non-limiting examples of the pad shown in FIGS. 3C-3F also show thesticker 44 on a top side of the pad 4. The sticker may have the same orsimilar shape as the pad 4 with an additional overlap over the pad 4.The overlap is hatched in FIGS. 3C-3F. The overlap of the sticker mayexceed the pad 4 in the range of 0.1 to 10 cm, or in the range of 0.1 to7 cm, or in the range of 0.2 to 5 cm, or in the range of 0.2 to 3 cm, orin the range of 0.3 to 1 cm. In one aspect, the overlap of the stickermay also have sticker slots 45 (see e.g. FIGS. 3E and 3F) close to thepad slots 43 allowing better adhesion of the overlap of the sticker 44to the uneven areas of the body part.

A treatment pad suitable for a treatment of submental area may cover thesubmentum as well as part of the neck. In one aspect, such a submentumpad may comprise active elements (e.g. electrodes) delivering energysuitable to provide contractions (e.g. electric current) only to thesubmentum (submental and submandibular triangle) and other activeelements (e.g. electrodes) delivering energy suitable for heating (e.g.radiofrequency) of the submentum and/or neck (e.g. carotid triangle,muscular triangle. Such a layout of the pad may be suitable fortreatment of double chin, wherein the heating is evenly distributedunder the pad and the contractions are provided only to some submentummuscles (e.g. digastric, mylohyoid and/or stylohyoid muscle), which maylay above the hyoid bone. In one aspect, the submentum pad may besymmetrical.

Pads may have different sizes with the surface areas ranging from 0.1 to150 cm² or from 0.2 to 125 cm² or from 0.5 to 100 cm² or in the range of1 to 50 cm² or in the range of 10 to 50 cm² or in the range of 15 to 47cm² or in the range of 18 to 45 cm². The pad may occupy approximately 1to 99% or 1 to 80% or 1 to 60% or 1 to 50% of the face. The number ofactive elements 13 (e.g. electrodes) within a single pad 4 ranges from 1to 100 or from 1 to 80 or from 1 to 60 or from 2-20 or from 3 to 10 orfrom 4 to 9. A thickness at least in a part of the pad 4 may be in therange of 0.01 to 15 mm or in the range of 0.02 to 10 mm or in the rangeof 0.05 to 7 mm or in the range of 0.1 to 2 mm.

In one aspect, the pad 4 may comprise one active element 13 (e.g.electrode) that provides one or more treatments (e.g. radiofrequencyenergy and electric current), whereas a plurality of such pads may beused to treat the same area during one treatment. For example instead ofusing one pad 4 with six active elements 13 (e.g. electrodes) which maybe used for treatment of a forehead, six pads 4 each with one activeelement 13 (e.g. electrode) may be used for the same treatment. Inanother aspect, the pad 4 may comprise one active element 13 (e.g.electrode) that provides one type of treatment/energy and plurality ofpads 4 that provides the same or different treatment/energy may be usedto treat the same area during one treatment. For example, instead of pad4 with one active element 13 (e.g. electrode) that providesradiofrequency energy and electric current, it may be possible to usetwo pads 4, one with active element 13 (e.g. electrode) that providesradiofrequency energy and the other one with active element 13 (e.g.electrode) that provides electric current.

Alternatively, only one or more active elements 13 (e.g. electrodes)themselves may be used instead of the pad 4 with a substrate and theactive element 13. In one aspect, the active element 13 (e.g. electrode)that provides one or more treatments (e.g. radiofrequency energy andelectric current) may be used to treat a body part of the patient. Inanother aspect, a plurality of active elements 13 (e.g. electrodes) maybe used to treat the same body part during one treatment. For exampleinstead of using one pad 4 with six active elements 13 (e.g. electrodes)which may be used for treatment of a forehead, six individual activeelements 13 (e.g. electrodes) may be used for the same treatment. Inanother aspect, the active element 13 (e.g. electrode) may provide onetype of treatment/energy and a plurality of active elements 13 (e.g.electrodes) that provides the same or different treatment/energy may beused to treat the same area during one treatment. For example, insteadof using pad 4 with at least one active element 13 (e.g. electrode) thatprovides radiofrequency energy and electric current, it may be possibleto use at least two individual active elements (e.g. electrodes), atleast one active element 13 (e.g. electrode) that providesradiofrequency energy and at least one active element 13 (e.g.electrode) that provides electric current.

In one aspect, the active elements 13 (e.g. electrodes or coils) mayoverlap each other at least partially. For example, the electrode may beat least partially situated under or over the coil in the pad 4.

Furthermore the pads 4 may have a shape that at least partiallyreplicates the shape of galea aponeurotica, procerus, levatar labiisuperioris alaeque nasi, nasalis, lavator labii superioris, zygomaticusminor, zygomaticus major, levator angulis oris, risorius, platysma,depressor anguli oris, depressor labii inferioris, occipitofrontalis(frontal belly), currugator supercilii, orbicularis oculi, buccinator,masseter, orbicularis oris or mentalis muscle when the pad 4 is attachedto the surface of the patient skin.

The pad 4 may be characterized by at least one aforementioned aspect orby a combination of more than one aforementioned aspect or by acombination of all aforementioned aspects.

The electromagnetic energy generator 6 or the secondary generator 9inside the main case may generate an electromagnetic or secondary energy(e.g. electric current) which may be delivered via a conductive lead toat least one active element 13 (e.g. electrode) attached to the skin,respectively. The active element 13 may deliver energy through itsentire surface or by means of a so-called fractional arrangement. Activeelement 13 may be an active electrode in a monopolar, unipolar, bipolaror multipolar radiofrequency system. In the monopolar radiofrequencysystem, energy is delivered between an active electrode (active element13) and a neutral electrode 7 with a much larger surface area. Due tomutual distance and difference between the surface area of the activeand neutral electrode, energy is concentrated under the active electrodeenabling it to heat the treated area. In the monopolar radiofrequencysystem, the energy may be delivered with the frequency in the range of100 kHz to 550 MHz or in the range of 200 kHz to 300 MHz or in the rangeof 250 kHz to 100 MHz or in the range of 300 kHz to 50 MHz or in therange of 350 kHz to 14 MHz. In the unipolar, bipolar or multipolarradiofrequency system, there is no need for neutral electrode 7. In thebipolar and multipolar radiofrequency system, energy is deliveredbetween two and multiple active electrodes with similar surface area,respectively. The distance between these electrodes determines the depthof energy penetration. In the unipolar radiofrequency system, only asingle active electrode is incorporated and energy is delivered to thetissue and environment surrounding the active electrode. The distancebetween the two nearest active elements 13 (e.g. the nearest neighboringsides of electrodes) in one pad 4 may be in the range of 0.1 to 100 mmor in the range of 0.3 to 70 mm or in the range of 0.5 to 60 mm or inthe range of 0.7 to 30 mm or in the range of 1 to 10 mm or in the rangeof 1 to 5 mm. The distance between the two nearest neighboring sides ofthe electrodes may mean the distance between the two nearest points ofneighboring electrodes.

A distance between the nearest point of the active element 13 (e.g.electrode) and the nearest edge of the pad 4 may be in the range of 0.1to 10 mm or in the range of 0.5 to 5 mm or in the range of 1 to 4 mm orin the range of 1 to 3 mm.

FIG. 4A-D represents a side view of possible configurations of the pad 4configured for contact therapy. Pads 4 may be made of flexible substratematerial 42—polyimide (PI) films, PTFE (e.g. Teflon®), PET, epoxy or PEfoam with an additional adhesive layer 40 on the underside. They may beof different shapes to allow the operator to choose according to thearea to be treated. Active elements 13 (e.g. electrodes) may have acircumference of annular, semicircular, elliptical, oblong, square,rectangular, trapezoidal or polygonal shape with a surface area in therange from 0.1 to 70 cm² or from 0.5 to 50 cm² or from 1 to 25 cm² orfrom 1 to 10 cm² or from 2 to 9.5 cm² or from 2.5 to 9 cm². The materialused for active elements (e.g. electrodes) may be copper, aluminum, leador any other conductive medium that can be deposited or integrated inthe pad 4. Furthermore the active elements 13 (e.g. electrodes) may bemade of silver, gold or graphite. Electrodes in the pad 4 may be printedby means of biocompatible ink, such as silver ink, graphite ink or acombination of inks of different conductive materials.

In some aspects, active elements 13 (e.g. electrodes) may be flexible aswell. A stiffness of the pad 4, the flexible substrate, or the activeelements 13 (e.g. electrodes) may be in a range of shore OO10 to shoreD80, in a range of shore OO30 to shore A100, in the range of shore A10to shore A80, or in the range of shore A20 to A70. In another aspect,the pad 4 may be made of flexible substrate with rigid active elements13 (e.g. electrodes) or some active elements 13 (e.g. electrodes) may berigid and some may be flexible with the above mentioned shore ranges(e.g. RF electrodes may be rigid and the electrodes for electrotherapymay be flexible and vice versa).

In one aspect, active elements 13 (e.g. electrodes) suitable for onetreatment (e.g. radiofrequency) may have different shapes and surfaceareas than the active elements 13 (e.g. electrodes) suitable for secondtreatment (e.g. electric current). For example, the radiofrequencyelectrodes may have a larger surface area than the electrotherapyelectrodes.

The thickness of the active elements 13 (e.g. electrode) may be in therange of 1 μm to 500 μm, in the range of 2 μm to 400 μm, in the range of3 μm to 300 μm, or in the range of 5 μm to 100 μm. In another aspect,the electrode thickness may be in the range of 0.2 mm to 10 mm, in therange of 0.4 mm to 8 mm, or in the range of 0.5 mm to 5 mm.

In one aspect, the active elements 13 (e.g. electrodes) may have asandwich structure where multiple conductive materials are depositedgradually on each other, e.g. a copper-nickel-gold structure. Forexample the copper may be deposited on the substrate with a thickness inthe range of 5 to 100 μm or in the range of 15 to 55 μm or in the rangeof 25 to 45 μm. The nickel may be deposited on the copper with athickness in the range of 0.1 to 15 μm or in the range of 0.5 to 8 μm orin the range of 1 to 6 μm. And the gold may be deposited on the nickelwith a thickness in the range of 25 to 200 nm or in the range of 50 to100 nm or in the range of 60 to 90 nm. Such a sandwich structure may bemade for example by an ENIG process.

In another aspect, the active elements 13 (e.g. electrodes) may be madeof copper and covered with another conductive layer, e.g. silver orsilver-chloride ink, carbon paste, or aluminum segments coupled to thecopper by conductive glue. Yet in another aspect the electrodes may beprinted e.g. by a silver ink, a silver-chloride ink, or a carbon pastewith the electrode thickness in the range of 1 to 100 μm or in the rangeof 5 to 55 μm or in the range of 8 to 45 μm.

The active element 13 (e.g. electrode) may have a shape that has a totalnumber of convex or concave arcs in a range of 1 to 12 or in a range of2 to 10 or in a range of 3 to 9 or in a range of 4 to 8. Additionally,the active element (e.g. electrode) may have a number of concave innerangles in a range of 1 to 7 or in a range of 1 to 6 or in a range of 1to 5 or in a range of 2 to 4, or the active element (e.g. electrode) mayhave a number of convex inner angles in a range of 1 to 10 or in a rangeof 1 to 9 or in a range of 2 to 8 in a range of 3 to 7. A possiblearrangement of convex-concave active elements 13 (e.g. electrodes) isdepicted in FIG. 3C.

The active element 13 (e.g. electrode providing radiofrequency energyand/or electric current) may be full-area electrode that has a fullactive surface. This means that the whole surface of the electrodefacing the patient is made of conductive material deposited orintegrated in the pad 4 as mentioned above.

In one aspect, the electrode (made of conductive material) facing thepatient may be with e.g. one or more apertures, cutouts and/orprotrusions configured for example to improve flexibility of theelectrode and/or pad, and/or reduce the edge effects and/or improvehomogeneity of delivered energy density and/or improve homogeneity ofprovided treatment. Apertures may be an opening in the body of theelectrode. A cutout may be an opening in the body of the electrode alongthe border of the electrode. Openings in the body of the electrode maybe defined by view from floor projections, which shows a view of theelectrode from above. The openings, e.g. apertures, cutouts and/or areasoutside of protrusions may be filed by air, dielectric material,insulation material, substrate of the pad, air or hydrogel. Theelectrode is therefore segmented in comparison to a regular electrode bydisruption of the surface area (i.e., an electrode with no apertures orcutouts). The two or more apertures or cutouts of the one electrode maybe asymmetrical. The one or more aperture and cutout may have e.g.rectangular or circular shape. The apertures and/or cutouts may haveregular, irregular, symmetrical and/or asymmetrical shapes. When theelectrode includes two or more apertures or cutouts, the apertures orcutouts may have the same point of symmetry and/or line of symmetry. Thedistance between two closest points located on the borders of twodifferent apertures and/or cutouts of the electrode may be in a rangefrom 1 μm to 10 mm or from 10 μm to 8 mm or from 20 μm to 5 mm or from50 μm to 3 mm or from 100 μm to 2 mm.

The active element (e.g. electrode) with one or more openings (e.g.apertures and/or cutouts) and/or protrusions may be framed by theconductive material and the inside of the frame may have a combinationof conductive material and the openings. As shown in FIGS. 9A-9C and 91,the frame 801 may create the utmost circumference of the electrode 800from the side facing the patient. The frame 801 may have a form ofannular, semicircular, elliptical, oblong, square, rectangular,trapezoidal or polygonal shape. The inside of the frame 801 may have astructure of a grid 802 as shown in FIGS. 9A and 9B with the apertures803. The frame 801 and the grid lines 802 are made of conductivematerial and are parts of the electrode 800. The frame 801 may be of thesame thickness as the thickness of the grid lines 802 or the thicknessof the frame 801 may be thicker than the grid lines 802 in the range of1% to 2000% or in the range of 10% to 1000% or in the range of 20% to500% or in the range of 50% to 200%. Additionally the frame 801 may bethinner than the grid lines 802 in the range of 0.01 times to 20 timesor in the range of 0.1 times to 10 times or in the range of 0.2 times to5 times or in the range of 0.5 times to 2 times.

The thickness of the frame 801, as depicted in FIGS. 9A-9C and FIG. 9I,may be in a range of 0.1 to 5 mm, in a range of 0.5 to 2.3 mm, in arange of 0.6 to 1.9 mm, or in a range of 0.8 to 1.6 mm. The thickness ofthe grid lines 802, as depicted in FIGS. 9A-91, may have the thicknessin a range of 0.01 to 2.3 mm, in a range of 0.05 to 1.1 mm, in a rangeof 0.1 to 0.8 mm, or in a range of 0.2 to 0.6 mm. The thickness of theframe 801 and the grid lines 802 is illustrated in FIG. 9I, which is azoom of the electrode 800 with the frame 801, the grid lines 802 and theapertures 803. It may be also possible to design the electrode such thatthe conductive material of the electrode is getting thinner from thecenter 804 of the electrode 800 as shown in FIG. 9C. The thinning stepbetween adjacent grid lines 802 in the direction from the center 804towards frame 801 may be in the range of 0.1 times to 10 times or in therange of 0.2 times to 5 times or in the range of 0.5 times to 2 timeswith the frame 801 having the thinnest line of conductive material.

In a first aspect, the total area of the electrode 800 (comprising theframe 801 and the grid lines 802) and all apertures 803 inside the frame801 of said electrode 800 may be in the range of 1 to 15 cm² or in therange of 2 to 8 cm² or in the range of 2.5 to 6 cm² or in the range of 3to 5 cm².

In a second aspect, the total area of the electrode 800 (comprising theframe 801 and the grid lines 802) and all apertures 803 inside the frame801 of said electrode 800 may be in the range of 1 to 20 cm² or in therange of 2 to 10 cm² or in the range of 2.5 to 8 cm² or in the range of3.5 to 7 cm².

In a third aspect, the total area of the electrode 800 (comprising theframe 801 and the grid lines 802) and all apertures 803 inside the frame801 of said electrode 800 may be in the range of 1 to 10 cm² or in therange of 2 to 6.5 cm² or in the range of 2.3 to 6 cm² or in the range of2.5 to 5.5 cm².

In a fourth aspect, the total area of the electrode 800 (comprising theframe 801 and the grid lines 802) and all apertures 803 inside the frame801 of said electrode 800 may be in the range of 1 to 20 cm² or in therange of 2 to 15 cm² or in the range of 3 to 12 cm² or in the range of 4to 10 cm².

A ratio of the area of the conductive material of the electrode 800(i.e. the frame 801 and the gridlines 802) to the total area of allapertures inside the frame 801 of the electrode 800 may be in the rangeof 1% to 50%, or in the range of 2% to 45% or in the range of 5% to 40%or in the range of 8% to 35% or in the range of 10% to 33%. Additionallythe ratio may be in the range of 1% to 20%, or in the range of 10% to40% or in the range of 33% to 67% or in the range of 50% to 70% or inthe range of 66% to 100%.

Alternatively, the electrode 800 may not be framed, e.g. it may have aform of a grid with no boundaries formed by openings 803 as shown inFIG. 9D. A ratio of conductive material to cutouts and/or apertures ofthe electrode may be in the range of 1% to 50%, or in the range of 2% to45% or in the range of 5% to 40% or in the range of 8% to 35% or in therange of 10% to 33%. Additionally, the ratio of conductive material toopenings of the electrode may be in the range of 1% to 20%, or in therange of 10% to 40% or in the range of 33% to 67% or in the range of 50%to 70% or in the range of 66% to 100%. Such a grated electrode may bevery advantageous. It may be much more flexible, it may ensure contactwith the patient that is more proper and it may have much betterself-cooling properties than full-area electrode.

With reference to FIG. 9E, a distance between the two closest parallelgrid lines 802 a and 802 b may be illustrated by at least one circle820, which may be hypothetically inscribed into an aperture and/orcutout 803 and between the two closest parallel grid lines 802 a and 802b and have at least one tangential point located on the first grid line802 a and at least one tangential point located on the second grid line802 b, thus having a diameter equal to the distance between the twoclosest parallel grid lines 802 a and 802 b. The at least onehypothetical circle 820 may have a diameter in a range from 0.001 to 10mm or 0.005 mm to 9 mm, or from 0.01 mm to 8 mm or 0.05 mm to 7 mm orfrom 0.1 mm to 6 mm, or from 0.2 mm to 5 mm or from 0.3 mm to 5 mm orfrom 0.5 mm to 5 mm.

With reference to FIG. 9F, in one aspect, an electrode 800 may havemultiple protrusions in the form of radial conductive lines 808separated by cutouts 803, wherein the multiple radial conductive lines808 are projected from one point of the electrode 805. The multipleradial conductive lines 808 are merged near the point 805 of theelectrode and together create a full conductive surface 810 around thepoint of the electrode 805. The radial conductive lines 808 projectedfrom the point 805 may have the same length or may have differentlengths. Additionally, some of the radial conductive lines 808 projectedfrom the point 805 may have the same length and some may have differentlengths.

With reference to FIG. 9G, in another aspect, the electrode 800 may havea base part 806 of a defined shape and protrusions (radial conductivelines) 808 separated by cutouts 803. The base part 806 may have a shapeof annular, semicircular, elliptical, oblong, square, rectangular,trapezoidal or polygonal. The base part 806 may be connected to theconductive leads.

With reference to FIG. 9H, in yet in another aspect, the electrode 800may have a base conductive line 807 and multiple protrusions (radialconductive lines) 808 separated by cutouts 803. The base conductive line807 is connected to all the radial conductive lines 808 as shown in FIG.9H. The base conductive line may also be connected to the conductivelead. The radial conductive lines 808 emerging from the base conductiveline 807 may have the same lengths and/or may have different lengths.

The distance between two closest protrusions 808 may be illustrated asat least one circle (similarly to the circle 820 in FIG. 9E), which maybe hypothetically inscribed into an aperture and/or cutout 803 andbetween two closest protrusions 808 and have at least one tangentialpoint located on the first protrusion and at least one tangential pointlocated on the second protrusion, thus having a diameter equal to thedistance between the two closest protrusions. The at least one circlemay have a diameter in a range from 0.001 to 10 mm or 0.005 mm to 9 mm,or from 0.01 mm to 8 mm or 0.05 mm to 7 mm or from 0.1 mm to 6 mm, orfrom 0.2 mm to 5 mm or from 0.3 mm to 5 mm or from 0.5 mm to 5 mm.

The protrusions 808 or cutouts 803 may have a symmetrical, asymmetrical,irregular and/or regular shape. The size, shape and/or symmetry ofindividual radial conductive lines may be the same and/or differentacross the electrode. For example each protrusion 808 may have the sameshape, the same dimension, the same direction and/or symmetry. Theprotrusions 808 may be characterized by a thickness and a length of theprotrusion, wherein the length is larger than the thickness by factor inthe range of 2 to 100, or in the range of 4 to 80, or in the range of 5to 70. The thickness of a protrusion may be in the range of 1 μm to 5 mmor in the range of 20 μm to 4 mm or in the range of 50 μm to 3 mm or inthe range of 100 μm to 2.5 mm or in the range of 120 μm to 2 mm or inthe range of 150 μm to 1.5 mm or in the range of 200 μm to 1 mm. Thelength of the protrusions may be in the range of 0.05 to 50 mm or in therange of 0.1 to 30 mm or in the range of 0.5 to 20 mm. The number ofprotrusions that one electrode may comprise may be in a range of 1 to1000, or of 5 to 500, or of 10 to 300, or of 15 to 250, or of 20 to 240.

The surface area of the electrode 800 with the protrusions 808 may be inthe range of 0.1 to 10 cm² or in the range of 0.3 to 9.5 cm² or in therange of 0.4 to 9 cm² or in the range of 0.5 to 8.5 cm².

In addition, all the possible electrode arrangements depicted in FIG.9F-H may be framed with a conductive frame 801, e.g. as shown in FIG.9A, wherein the frame 801 is also a part of the electrode.

The total number of apertures and/or cutouts in one electrode regardlessof the parallel cuts may be in a range of 5 to 250, or of 10 to 200, orof 15 to 170, or of 20 to 150, or of 300 to 1500, or of 400 to 1400, orof 500 to 1300, or of 600 to 1200.

In one aspect, where one or more active elements are in the form of anelectrode, which is grated (FIGS. 9A-9D), the energy flux of one or moregrated electrodes may be calculated as an energy flux of the grid 802and/or the frame 801 of the active element and may be in the range of0.001 W/cm² to 1500 W/cm² or 0.01 W/cm² to 1000 W/cm² or 0.5 W/cm² to500 W/cm² or 0.5 W/cm² to 200 W/cm² or 0.5 W/cm² to 100 W/cm² or 1 W/cm²to 70 W/cm².

In another aspect, where one or more active elements are in the form ofan electrode with openings and/or protrusions (FIGS. 9F-9H), the energyflux of one or more protruded electrodes may be calculated as an energyflux of the base part 806 or base conductive line 807 and theprotrusions 808 of the active element and may be in the range of 0.001W/cm² to 1500 W/cm² or 0.01 W/cm² to 1000 W/cm² or 0.5 W/cm² to 500W/cm² or 0.5 W/cm² to 200 W/cm² or 0.5 W/cm² to 100 W/cm² or 1 W/cm² to70 W/cm².

As shown in FIGS. 4A and 4B, the active elements 13 (e.g. electrode) maybe partially embedded within the flexible substrate layer 42 or adhesivelayer 40 or in the interface of the flexible substrate layer 42 andadhesive layer 40. The active elements 13 (e.g. electrode) may besupplied and controlled independently by multiple conductive leads 41 a(FIG. 4A) or they may be conductively interconnected andsupplied/controlled via a single conductive lead 41 b (FIG. 4B). Themultiple conductive leads 41 a may be connected to the active elements13 (e.g. electrode) via a free space (e.g. hole) in the flexiblesubstrate layer 42. The free space (e.g. hole) may have dimensions suchthat each conductive lead 41 a may fit tightly into the substrate layer42, e.g. the conductive lead 41 a may be encapsulated by a flexiblesubstrate layer 42. Furthermore, the free space (e.g. hole) itself maybe metalized and serve as a connection between respective conductiveleads 41 a and active elements 13 (e.g. electrodes). As shown in FIG.4A, the active elements 13 (e.g. electrodes) may also be deposited onthe underside of the flexible substrate 42 and may be covered by theadhesive layer 40 on the sides, which are not coupled to the substrate42.

In another aspect, the active elements 13 (e.g. electrodes) may beembedded in the flexible substrate 42 such, that the underside of thesubstrate 401 and the underside of the active elements 13A-D are in oneplane, as shown in FIG. 4C. For clarity, the flexible substrate 42 ishatched in FIG. 4C. The substrate 42 may have no free space forconductive leads 41 a, as the conductive lead may be directly coupled tothe top side of the active element (e.g. electrode) as shown in activeelements 13A and 13B in FIG. 4C. Alternatively, the flexible substratemay have a free space (e.g. hole or metalized hole) for coupling theconductive leads 41 a to the active elements (e.g. electrodes), whichmay be thinner than the substrate, as shown in active elements 13C and13D in FIG. 4C.

Another possible arrangement of the active elements (e.g. electrodes) inthe pad 4 is represented in FIG. 4D. In a first aspect, the activeelement 13E may be deposited on the top side of the substrate 402 such,that the underside of the active element 13E is deposited on the topside of the substrate 402, creating an interface of the active element13E and substrate 42 on the top side of the substrate 402. In a secondaspect, the active element 13F may be embedded in the substrate 42 fromthe top side of the substrate 402, such that the top side of the activeelement (e.g. electrode) and the top side of the substrate 402 lies inone plane. In this case, the thickness of the active element 13F is lessthan thickness of the substrate 42. In a third aspect the active element13G may be deposited on the top side of the surface 402 similarly to theactive element 13E but even more, the active element 13G is partiallyembedded in the substrate 42 from the top side of the substrate. In allthese cases (active elements 13E-G), the substrate 42 is perforatedallowing the coupling of adhesive layer 40 with the active elements13E-G through the perforations 403.

Alternatively, the active element (e.g. electrode) may be fully embeddedin the substrate and protrude from its top side or underside. Thus, thethickness of the active element (e.g. electrode) may be bigger than thethickness of the substrate.

In addition, combinations of pad 4 structures mentioned above may bepossible, e.g. one active element (e.g. first electrode) is deposited onthe underside of the pad 4 and another active element (e.g. secondelectrode) is embedded in the pad 4.

In case of a single conductive lead connection, the active elements 13(e.g. electrode) may be partially embedded inside the flexible substrate42 or adhesive layer 40 or in the interface of the flexible substratelayer 42 and adhesive layer 40, and the active elements 13 (e.g.electrode) may be connected via single conductive lead 41 b which may besituated in the flexible substrate 42 or at the interface of theflexible substrate 42 and adhesive layer 40, as shown in FIG. 4B. Thesingle conductive lead 41 b may leave the pad 4 on its lateral or topside in a direction away from the patient. In both cases the conductivelead 41 a or 41 b does not come into contact with the treatment area.

Additionally, the active elements 13 (e.g. electrode) may be partiallyembedded within the flexible substrate 42 and the adhesive layer 40 maysurround the active elements 13 such that a surface of active elements13 may be at least partially in direct contact with the surface of atreatment area.

Moreover, the top side of the pad 4 may be protected by a cover layer410, which is shown for simplicity only in FIG. 4C.

In one aspect, all the layers from top to the bottom may be configuredas depicted in FIG. 4E, wherein the bottom means the part that is facingtowards the patient during the therapy. Layer 451 is a top non-stickingpart of a sticker 450. Layer 452 is a bottom sticking part (e.g. medicalfoam tape) of the sticker, which attaches the sticker 451 to thesubstrate 421 (e.g. PET based) of the pad 420 and/or attaches thesticker 451 to the patient. On the bottom of the substrate 421, theremay be a conductive lead 422 that is separated from the active element(e.g. electrode) 424 by N dielectric layers 423-1 to 423-N (where N is anon-negative integer) of the same or different dielectric properties.The active element 424 (e.g. electrode) may be connected with theconductive lead 422 through the hole connection 425 in the dielectriclayer(s), hatched in the FIG. 4E. The active element 424 (e.g.electrode), the conductive lead 422 and the hole connection 425 may beprinted by the same biocompatible material, such as silver ink,silver-chloride ink, graphite ink or a combination of inks of differentconductive materials or may be made by any other know technology ofdeposition of conductive materials (e.g. lithography). The adhesivelayer (e.g. hydrogel) 430 may be deposited on the bottom of the activeelement 424 (e.g. electrode) and may be covered by a releaser 440 whichis removed prior to the attaching of the pad to the patient.

In other aspects, the layers may be different and it may be possible toremove or add more layers to the structure of the pad 420 that is shownin FIG. 4E. For example, as described above, the adhesive layer 430 (andreleaser 440) may not be a part of the pad 420, but instead the adhesivelayer 430 may be applied directly on the patient skin prior to thecoupling of the pad 420 on the patient. In another aspect, the sticker450 may not be presented on the pad 420. Yet in another aspect thesubstrate 421 and/or dielectric layer(s) 423-1-423-N may not be part ofthe pad 420. Moreover, in one aspect, only the active element 424 withconducive lead 422 may be the part of the pad 420. The aspects may becombined together.

A pad 4 may include flexible substrate 500, which may comprise a centralpart 501 and one or more segments 502, which may move at least partiallyindependently from each other as shown in FIG. 5A. The flexiblesubstrate may have a thickness in a range of 1 to 500 μm or in a rangeof 1 to 350 μm or in a range of 1 to 200 μm or in a range of 5 to 100 μmor in a range of 10 to 75 μm or in a range of 15 to 65 μm. The centralpart or the segments may include a sensor 15. The number of segments onthe pad 4 may be in the range of 1 to 100, or in the range of 1 to 80 orin the range of 1 to 60 or in the range of 2 to 20 or in the range of 3to 10 or in the range of 4 to 9, wherein each segment may comprise atleast one active element 13 (e.g. electrode). The neighboring segmentsmay be at least partially separated by slots 503.

Conventional therapy pads have routinely been made on a singlenon-segmented substrate which in some cases includes a flexible metalmaterial or a polymeric material with a layer of metallic materialdeposited thereon.

As seen in FIG. 5A, the proposed segmented pad 4 may be more flexibleand may provide a greater amount of contact with the patient thanconventional pads routinely used. The substrate 500 of the pad 4 isdivided into central part 501 and a plurality of connected segments 502.The plurality of segments 502 may move at least partially independentlyfrom one another. The individual segments 502 may be at least partiallyphysically detached from one another by, for example, one or more slots503, or other open area between neighboring segments 502. The pluralityof segments 502 may be physically coupled together by a central part 501including one or more conductive leads 506. In one aspect, the centralpart 501 may also include one or more active elements 13 (e.g.electrodes). In another aspect, each active element 13 (e.g. electrode)may be partially deposited in the central part 501 and partially in thecorresponding segment 502. In another aspect, some active elements (e.g.electrodes) may be deposited on the central part and some activeelements (e.g. electrodes) may be deposited at least partially on thesegments.

As shown in FIG. 5A, the slots 503 may extend from the central part 501of the substrate 500 of the pad 4 proximate to a conductive lead 508 andbetween neighboring segments 502 to an edge of the substrate 500.Providing for the plurality of segments 502 of the pad 4 to move atleast partially independently from one another may facilitateconformance of the pad 4 to curves or contours of a patient's body. Asegmented pad 4 as illustrated in FIG. 5A may provide for a greaterarea, or a greater percentage of the total area, of the pad 4 portion tobe in contact with the patient's body than if the pad 4 were formed as asingle, non-segmented substrate. In addition, the segments 502 maycomprise a perforated gap 503′ shown in FIG. 5A, which also providesgreater conformance of the pad 4 to curves or contours of a patient'sbody.

The shapes and positions of the segments 502 and/or the slots 503 may beprovided in different configurations from those illustrated in FIG. 5A.For example, the segments 502 may include rounded or squared ends orhave different dimensional ratios than illustrated. The slots 503 may becurved, squared, triangular, oblong, polygonal or may include re-entrantportions extending between one of the segments 502 and the central part501. The slots 503 me also be a combination of the shapes mentionedabove, e.g. a combination of a triangular slot with the curved end asillustrated in FIG. 5B representing a detail of one possible slotarrangement between two neighboring segments 502′ and 502″. The slotsmay be very thin or may be wide, wherein the width of the slot is may beillustrated in one example as follows: First, an imaginary curved orstraight line 520 passes through the center of the slot such that itdivides the slot into two symmetrical parts 503 a and 503 b,respectively. The width is then given by a second imaginary line 530which is perpendicular to the first imaginary line 520 and which wouldconnect the edges of the neighboring segments facing towards the slot502 a and 502 b, and where the second imaginary line 530 is at adistance of at least 1 mm away from the beginning of the slot 503 c. Thebeginning of the slot 503 c is a point in the slot 503 closest to thecentral part 501 of the substrate 500 of the pad 4 as seen in FIG. 5B.The first imaginary line 520 is represented by a dashed line in the FIG.5B and the second imaginary line 530 is represented as a dotted line inFIG. 5B. The width of the slot w_(S) may be in the range of 100 μm to 10mm or in the range of 500 μm to 8 mm or in the range of 600 μm to 7 mmor in the range of 800 μm to 5 mm.

Each segment 502 of the substrate 500 may comprise an active element 13(e.g. electrode) on a portion of, or the entirety of, the segment 502.

The central part 501 may have a proximal end 504 and a distal end 505,wherein the proximal end 504 of the central part 501 may pass or may beconnected to the connecting part 507. The central part 501 is connectedto the connecting part 507 in the area of a dotted circle in FIG. 5A.Connecting part 507 may comprise a conductive lead 508 for each activeelement 13 (e.g. electrode) 13 a-13 f in FIG. 5A, or sensor(s) 15included in a pad 4, wherein all conductive leads 508 of the connectingpart 507 are entering the pad 4 in the proximal end 504 of the centralpart 501 of the pad 4. Conductive leads 508 are mainly led by thecentral part 501 until they reach the respective segment and its activeelement(s) or sensor(s), thus there may be no conductive lead at thedistal end 505 of the central part 501 as shown in FIG. 5A. Theconductive leads 506 may be led on the top side of the substrate 500(e.g. the side facing away from the patient) and may be covered by acover layer (e.g. by synthetic polymer like polyimide). In one aspect,the underside of the pad 4 (the side facing towards the body area of thepatient) may also be at least partially covered by the cover layer,mainly in the area where the pad 4 is coupled to the connecting part507—dotted circle in FIG. 5A, avoiding the active elements 13; toimprove mechanical reinforcements of this part of the pad 4, to amongother benefits. The cover layer (e.g. polyimide film or foam) may have athickness in a range of 5 to 50 μm or in a range of 7 to 35 μm or in arange of 10 to 30 μm. In another aspect, the conductive leads 506 may beled on the bottom side of the substrate 500 (e.g. side facing towardsthe patient) and may be covered by a dielectric layer to prevent thecontact of the conductive leads 506 with the patient (e.g. the coverlayer of polyimide film or foam).

The connecting part 507 may be flexible or partially elastic. Theconnecting part may be made of flexible PCB with the cover layer as anisolation layer on the top side and/or the underside of the connectingpart 507.

In one aspect, the connecting part 507 may be printed on the substrate,which is made of the same material as the substrate 500 of the pad, andit may be printed (e.g. by metal ink) on the underside of the substrate500 and covered by the cover layer, so it does not come into a contactwith the patient.

The connecting part may have a connector at its ends, which may berigid. The connector may be one of a USB type A, USB type B, USB type C,USB Micro B, DC power cord, AC power cord, computer power cable,firewire, RJ11, fiber connector, USB 3.0, mini display, pin connector,SMA, DVI, BNC, IDE, PS/2, RCA, display port, PSU, SATA, mSATA, DB9,RJ45, RS232 or any other connector know in the art. The pin connectormay have number of pins in a range of 5 to 60 or in a range of 10 to 44or in a range of 15 to 36 or in a range of 20 to 34. Alternatively, theconnector may be made on the flexible PCB with an attached stiffenerunderneath used to stiffen the connector against out of planedeformation. The stiffener may be made of a non-conductive materialincluding but not limited to plastic or fiberglass. The stiffener mayhave a thickness in a range of 0.1 to 5 mm or in a range of 0.5 to 2 mmor in a range of 1 to 1.5 mm. The flexible PCB connector may comprise anumber of contacts in the range of 5 to 60 or in a range of 10 to 44 orin a range of 15 to 36 or in a range of 20 to 34.

In one aspect, the pad 4, the connecting part 507 and the connector mayall be part of the applicator.

The interconnecting block 3 or the main unit 2 may comprise one or moresockets configured to connect the connecting part via the connector onthe opposite side to the side where the pad 4 is situated, wherein theone or more sockets are configured to connect an arbitrary pad and/orapplicator. Alternatively, the interconnecting block or the main unitmay comprise multiple sockets, each socket configured to connect onespecific pad and/or applicator for a specific treatment area. The socketmay be configured such that it will automatically determine a currentlyconnected pad and/or applicator. The information about the connected padand/or applicator may be read out from the memory of the pad.Alternatively, the memory may be part of the connector. After theconnection, the connector may be linked with the control unit 11 (e.g.CPU). The control unit 11 (e.g. CPU) may provide one or morepredetermined treatment protocols to the user via the human machineinterface 8 after the detection of the pad in the socket. For example ifonly a forehead pad is connected, the system may automatically detectthis specific pad and propose only a treatment of a forehead of thepatient, not allowing the user to set a treatment of other body parts ofthe patient. Furthermore, the connector may comprise cutouts, grooves,slots, holes and/or notches for locking the connector in the socket. Thesocket may also comprise a safeguard preventing unintentional connectionof the connector in the socket.

In one aspect, the connector may comprise a symbol indicating on whichbody part the pad and/or the applicator is designated to treat.

In addition, a supplementary connection may be used between the mainunit 2 and the connecting part; or between the interconnecting block 3and the connecting part in order to extend the connection between themain unit 3 and the pad 4 or interconnecting block 3 and the pad 4.

Average pad thickness may be in the range of 10 μm to 2000 μm or in therange of 50 μm to 1000 μm or in the range of 80 μm to 300 μm or in therange of 100 μm to 200 μm.

The apparatus configured in a fractional arrangement may have the activeelement 13 (e.g. electrode) comprising a matrix formed by active pointsof defined size. These points are separated by inactive (and thereforeuntreated) areas that allow faster tissue healing. The surfacecontaining active points may make up from 1 to 99% or from 2 to 90% orfrom 3 to 80% or from 4 to 75% of the whole active element area (activeand inactive area). The active points may have blunt ends at the tissuecontact side that do not penetrate the tissue, wherein the surfacecontacting tissue may have a surface area in the range of 500 μm² to 250000 μm² or in the range of 1000 μm² to 200 000 μm² or in the range of200 μm² to 180 000 μm² or in the range of 5000 μm² to 160 000 μm². Theblunt end may have a radius of curvature of at least 0.05 mm. A diameterof the surface contacting tissue of one active point may be in the rangeof 25 μm to 1500 μm or in the range of 50 μm to 1000 μm or in the rangeof 80 μm to 800 μm or in the range of 100 μm to 600 μm.

Additionally, the device may employ a safety system comprising thermalsensors and a circuit capable of adjusting the therapy parameters basedon the measured values. One or more thermal sensors, depending on thenumber and distribution of active elements 13 (e.g. electrodes), may beintegrated onto pad 4 to collect data from different points so as toensure homogeneity of heating. The data may be collected directly fromthe treatment area or from the active elements 13 (e.g. electrodes). Ifuneven heating or overheating is detected, the device may notify theoperator and at the same time adjust the therapy parameters to avoidburns to the patient. Treatment parameters of one or more activeelements (e.g. electrodes) might be adjusted. The main therapyparameters are power, duty cycle and time period regulating switchingbetween multiple active elements 13 (e.g. electrodes). Therapy may beautomatically stopped if the temperature rises above the safe threshold.

Furthermore, impedance measurement may be incorporated in order tomonitor proper active element 13 (e.g. electrodes) to skin contact. Ifthe impedance value is outside the allowed limits, the therapy may beautomatically suspended and the operator may be informed about potentialcontact issues. In that case, the active element (e.g. electrode) mayact as an impedance sensor itself. The impedance may be measured by oneor more active elements (e.g. electrodes) of the pad before, during orafter the treatment.

In one aspect, the measurement of the voltage pulses and/or the currentpulses and/or phase shift may be used to monitor the course of theelectric current therapy. As one non-limiting example, the electriccurrent pulses may have a rectangular shape and the correspondingmeasured voltage pulses may have a shape depending on the amount of thecurrent passing through the patient. Thus, it may be possible todetermine the correct contact of the active element 13 (e.g. electrode)with the patient based on the measurement of the voltage pulses.

Control unit 11 (e.g. CPU) may be incorporated onto the pad 4 itself orit may form a separate part conductively connected to the pad 4. Inaddition to the control mechanism, control unit 11 (e.g. CPU) may alsocontain main indicators (e.g. ongoing therapy, actual temperature andactive element to skin contact).

FIG. 6 shows some delivery approaches of apparatus for contact therapy.

It is possible to switch between multiple active elements 13 (e.g.electrodes) within the single pad 4 in such a way so that the multipleactive elements 13 deliver energy simultaneously, successively or in anoverlapping method or any combination thereof. For example, in the caseof two active elements: in the simultaneous method, both active elements(e.g. electrodes) are used simultaneously during the time interval e.g.,1-20 s. In the successive method, the first active element (e.g. firstelectrode) is used during the first time interval e.g., from 1 s to 10s. The first active element is then stopped and the second activeelement (e.g. second electrode) is immediately used in a subsequent timeinterval e.g., from 10 s to 20 s. This successive step may be repeated.In the overlapping method, the first active element (e.g. firstelectrode) is used during a time interval for e.g., 1-10 s, and thesecond active element (e.g. second electrode) is used in a secondoverlapping time interval for e.g., 1-10 s, wherein during the secondtime interval the first active element and the second active element areoverlapping e.g., with total overlapping method time of 0.1-9.9 s.Active elements 13 (e.g. electrodes) may deliver energy sequentially inpredefined switching order or randomly as set by operator via humanmachine interface 8. Schema I in FIG. 6 represents switching betweenpairs/groups formed of non-adjacent active elements 13 (e.g. electrodes)located within a pad 4. Every pair/group of active elements 13 (e.g.electrodes) is delivering energy for a predefined period of time (darkgray elements in FIG. 6—in schema I elements 1 and 3) while theremaining pairs/groups of active elements 13 (e.g. electrodes) remaininactive in terms of energy delivery (light gray elements in FIG. 6—inschema I elements 2 and 4). After a predefined period of time, energy isdelivered by another pair/group of active elements 13 (e.g. electrodes)and the initial active elements (e.g. electrodes) become inactive. Thisis indicated by arrows in FIG. 6. Switching between pairs/groups ofactive elements 13 (e.g. electrodes) may continue until a targettemperature is reached throughout the entire treatment area or apredefined energy is delivered by all active elements 13 (e.g.electrodes). Schema II in FIG. 6 represents switching of all activeelements 13 (e.g. electrodes) within the pad 4 between state ON whenactive elements (e.g. electrodes) are delivering energy and OFF whenthey are not delivering energy. The duration of ON and OFF states mayvary depending on predefined settings and/or information provided bysensors, e.g. thermal sensors. Schema III in FIG. 6 shows sequentialswitching of individual active elements 13 (e.g. electrodes) within apad 4. Each active element 13 (e.g. electrode) is delivering energy forpredefined periods of time until a target temperature is reachedthroughout the entire treatment area or a predefined energy is deliveredby all active elements 13 (e.g. electrodes). This sequential switchingmay be executed in a clockwise or anticlockwise order. Schema IV in FIG.6 represents a zig-zag switching order during which preferablynon-adjacent active elements 13 (e.g. electrodes) deliver energysequentially until all active elements 13 (e.g. electrodes) within a pad4 have been switched ON. Each active element 13 (e.g. electrode)delivers energy for a predefined period of time until a targettemperature is reached throughout the entire treatment area or apredefined energy is delivered by all active elements (e.g. electrodes).

The control unit (e.g. CPU) may be configured to control the stimulationdevice and provide treatment by at least one treatment protocolimproving of visual appearance. Treatment protocol is set of parametersof the primary electromagnetic energy and the secondary energy ensuringthe desired treatment effect. Each pad may be controlled by the controlunit (e.g. CPU) to provide same or alternatively different protocol.Pair areas or areas where symmetrical effect is desired may be treatedby the same treatment protocol. Each protocol may include one or severalsections or steps.

As a non-limiting example: in case of applying the radiofrequency energyby the active elements (e.g. electrodes) one by one as shown in SchemaIII and IV in FIG. 6, the time when one active element (e.g. electrode)delivers the radiofrequency energy to the tissue of the patient may bein the range of 1 ms to 10 s or in the range of 10 ms to 5 s or in therange of 50 ms to 2 s or in the range of 100 ms to 1500 ms. Twoconsecutive elements may be switched ON and OFF in successive oroverlapping method. Additionally, the delivery of the radiofrequencyenergy by two consecutive active elements (e.g. electrodes) may beseparated by the time of no or low radiofrequency stimulation, such thatnon of the two consecutive active elements (e.g. electrodes) provides aradiofrequency energy causing heating of the treatment tissue. The timeof no or low radiofrequency stimulation may be in the range of 1 μs to1000 ms, or in the range of 500 μs to 500 ms or in the range of 1 ms to300 ms or in the range of 10 ms to 250 ms.

In case of the treatment when more than one pad is used, the sequentialswitching of the active elements (e.g. electrodes) providingradiofrequency treatment may be provided within each pad independentlyof the other pads or active elements (e.g. electrodes) may deliverenergy sequentially through all pads.

As an example for three dependent pads, each with two active elements(e.g. electrodes):

first step—the radiofrequency energy may be provided by active elementone in the first pad, wherein other active elements are turned off,second step—the active element two of the first pad is turned on and therest of the active elements are turned off,third step—the active element one of the second pad is turned on and therest of the active elements are turned off,fourth step—the active element two of the second pad is turned on andthe rest of the active elements are turned off,fifth step—the active element one of the third pad is turned on and therest of the active elements are turned off,sixth step—the active element two of the third pad is turned on and therest of the active elements are turned off.

Another non-limiting example may be:

first step—the radiofrequency energy may be provided by active elementone in the first pad, wherein other active elements are turned off,second step—the active element one of the second pad is turned on andthe rest of the active elements are turned off,third step—the active element one of the third pad is turned on and therest of the active elements are turned off,fourth step—the active element two of the first pad is turned on and therest of the active elements are turned off,fifth step—the active element two of the second pad is turned on and therest of the active elements are turned off,sixth step—the active element two of the third pad is turned on and therest of the active elements are turned off.

In case that the pads are treating pair areas (e.g. cheeks, thighs orbuttocks), where symmetrical effect is desired, the pair pads may bedriven by the same protocol at the same time.

An example of treatment protocol for one pad delivering theradiofrequency energy for heating of the patient and the electriccurrent causing the muscle contractions is as follow. The protocol mayinclude a first section where electrodes in one pad may be treated suchthat the electrodes provide an electric current pulses modulated in anenvelope of increasing amplitude modulation (increasing envelope)followed by constant amplitude (rectangle envelope) followed bydecreasing amplitude modulation (decreasing envelope), all these threeenvelopes may create together a trapezoidal amplitude modulation(trapezoidal envelope). The trapezoidal envelope may last 1 to 10seconds or 1.5 to 7 seconds or 2 to 5 seconds. The increasing,rectangle, or decreasing envelope may last for 0.1 to 5 seconds or 0.1to 4 seconds or 0.1 to 3 seconds. The increasing and decreasing envelopemay last for the same time, thus creating a symmetrical trapezoidenvelope. Alternatively, the electric current may be modulated to asinusoidal envelope or rectangular envelope or triangular envelope. Therespective envelopes causing muscle contractions may be separated bytime of no or low current stimulation, such that no muscle contractionis achieved or by a radiofrequency energy causing the heating of thetissue. During this time of no muscle contraction, the pressure massageby suction openings may be provided, which may cause the relaxation ofthe muscles. The first section may be preprogrammed such that electrodeson various places of the pad may be switched in time to providealternating current pulses wherein some other electrodes in the pad maynot provide any alternating current pulses but only RF pulses causingheating of the tissue. All electrodes in the pad may ensure providing(be switched by the switching circuitry 14 that is controlled by thecontrol unit 11 to provide) RF pulses for heating the tissue during thesection of protocol or protocol, while only a limited amount of theelectrodes may provide (be switched by the switching circuitry 14 toprovide) alternating currents for muscle contracting during the sectionof protocol or protocol. The device may be configured such that thefirst section lasts for 1-5 minutes.

A second section may follow the first section. The second section may bepreprogrammed such that different electrodes than the ones used in thefirst section on various places of the pad may be switched in time toprovide alternating current pulses wherein some other electrodes (sameor different electrodes than the ones used in the first section) in thepad may not provide any alternating current pulses but only RF pulsescausing heating of the tissue.

A third section may follow the second section. The third section may bepreprogrammed such that different electrodes than the ones used in thesecond section on various places of the pad may be switched in time toprovide alternating current pulses wherein some other electrodes (sameor different electrodes than the ones used in the second section) in thepad may not provide any alternating current pulses but only RF pulsescausing heating of the tissue.

An example of a treatment protocol for three dependent pads, e.g. onepad for treatment of the forehead (forehead pad) and two pads fortreatment of the left and right cheeks (left and right cheek pad),delivering radiofrequency energy for heating of the patient and electriccurrent causing muscle contractions is as follows: The first pad, e.g.for treatment of the forehead, may have six active elements, e.g.electrodes E1-E6; the second pad, e.g. for treatment of the left cheek,may comprise seven active elements, e.g. electrodes E7-E13; and thethird pad, e.g. for treatment of the right cheek, may comprise sevenactive elements, e.g. electrodes E14-E20. Some electrodes may beconfigured to provide radiofrequency energy and some electrodes may beconfigured to provide both radiofrequency energy and electric current.

The radiofrequency energy may be a monopolar radiofrequency energy witha frequency in the range of 100 kHz to 550 MHz or in the range of 250kHz to 500 MHz or in the range of 350 kHz to 100 MHz or in the range of350 kHz to 14 MHz. The radiofrequency energy may be delivered with arectangular envelope which may last for 200 to 3000 ms or for 250 to2000 ms or for 300 to 1800 ms or for 350 to 1500 ms. Alternatively, theradiofrequency envelope (hereinafter RF envelope) may be modulated to asinusoidal envelope or triangular envelope or trapezoidal envelope.

The electric current may be a bipolar (biphasic) rectangular AC TENScurrent with a frequency in the range of 10 Hz to 10 kHz or in the rangeof 25 Hz to 1 kHz or in the range of 50 to 500 Hz or in the range of 100to 300 Hz modulated to a trapezoidal envelope, which may last 1 to 10seconds or 1.5 to 7 seconds or 2 to 5 seconds. An increasing,rectangular, or decreasing envelope of the trapezoidal envelope may lastfor 0.1 to 5 seconds or 0.1 to 4 seconds or 0.1 to 3 seconds. Theincreasing and decreasing envelopes may have the same duration, thuscreating a symmetrical trapezoidal envelope. Alternatively, the electriccurrent envelope (hereinafter EC envelope) may be modulated to asinusoidal envelope or rectangular envelope or triangular envelope.

The protocol may have a cycle that includes sections. The number ofprotocol sections in one cycle may be the same number as the totalnumber of used electrodes within all pads used for the treatment or maybe different. The number of sections per pad may be in the range of 1 to100, or of 1 to 80, or of 1 to 60, or of 2 to 20, or of 3 to 10, or of 4to 9. The number of sections per cycle may be in the range of 1 to 100,or of 1 to 80, or of 1 to 60, or of 2 to 40, or of 3 to 35, or of 4 to30. Each protocol section may follow the previous protocol section, e.g.the second section follows the first section. Each protocol section maylast for 200 to 3000 ms or for 250 to 2000 ms or for 300 to 1800 ms orfor 350 to 1500 ms. The cycle may repeat from 30 to 300, or from 50 to250, or from 80 to 220, or from 100 to 200, times per treatment.Alternatively, the cycle may repeat from 150 to 600, or from 190 to 550,or from 200 to 520, or from 210 to 500 times per treatment. In oneaspect the treatment protocol may repeat the same cycle. In anotheraspect the treatment protocol may repeat different cycles, wherein thecycles may be different in the number of sections, and/or duration ofsections, and/or sequence of activating and/or deactivating theelectrodes, and/or parameters set for RF and/or EC envelopes (e.g. shapeof envelope, amplitude, frequency, duration and so on), and/orparameters set for radiofrequency and/or parameters of electric current.

An example of a cycle including 20 sections may be as follows:

In the first section, the electrode E2 delivers the RF envelope.

In the second section, the electrode E7 delivers the RF envelope.

In the third section, the electrode E14 delivers the RF envelope.

In the fourth section, the electrode E5 delivers the RF envelope.

In the fifth section, the electrode E8 delivers the RF envelope.

Throughout the first to fifth sections, the electrode pairs E1-E4,E3-E6, E9-E10, E11-E12, E16-E17 and electrode pair E18-E19 deliver theEC envelope causing muscle contractions under the first, second andthird pads, e.g. under the forehead pad, the left cheek pad and theright cheek pad.

In the sixth section, the electrode E15 delivers the RF envelope.

In the seventh section, the electrode E13 delivers the RF envelope.

In the eighth section, the electrode E20 delivers the RF envelope.

In the ninth section, the electrode E1 delivers the RF envelope.

In the tenth section, the electrode E3 delivers the RF envelope.

Throughout the sixth to tenth sections, the electrode pairs E9-E10,E11-E12, E16-E17 and electrode pair E18-E19 deliver the EC envelopecausing muscle contractions under the second and third pads, e.g. underthe left and right cheek pads.

In the eleventh section, the electrode E6 delivers the RF envelope.

In the twelfth section, the electrode E4 delivers the RF envelope.

In the thirteenth section, the electrode E9 delivers the RF envelope.

In the fourteenth section, the electrode E16 delivers the RF envelope.

In the fifteenth section, the electrode E12 delivers the RF envelope.

Throughout the eleventh to fifteenth sections, no electrode pairsdeliver the EC envelope, causing the muscles to relax.

In the sixteenth section, the electrode E19 delivers the RF envelope.

In the seventeenth section, the electrode E10 delivers the RF envelope.

In the eighteenth section, the electrode E17 delivers the RF envelope.

In the nineteenth section, the electrode E11 delivers the RF envelope.

In the twentieth section, the electrode E18 delivers the RF envelope.

Throughout the sixteenth to twentieth sections, the electrode pairsE1-E4 and E3-E6 deliver the EC envelope causing muscle contractionsunder the first pad, e.g. under the forehead pad.

Another example of a treatment protocol for three dependent pads 4controlled by the control unit 11, e.g. one pad for treatment of theforehead (forehead pad) and two pads for treatment of the left and rightcheeks (left and right cheek pad), delivering radiofrequency energy forheating of the patient and electric current causing muscle contractionsis as follows: The first pad, e.g. for treatment of the forehead, mayhave six active elements, e.g. electrodes E1-E6; the second pad, e.g.for treatment of the left cheek, may comprise six active elements, e.g.electrodes E7-E12; and the third pad, e.g. for treatment of the rightcheek, may comprise six active elements, e.g. electrodes E13-E18. Someactive elements may be configured to provide either electromagneticenergy (e.g. radiofrequency energy) or secondary energy (e.g. electriccurrent), and some active elements may be configured to provide bothelectromagnetic energy and secondary energy. Alternatively, each activeelement may be part of one pad 4 (thus using eighteen pads instead ofthree) or it may be possible to use just the active elements (e.g.electrodes without the substrate of the pad) attached to treated areas.Each protocol section may last for 200 to 3000 ms or for 250 to 2000 msor for 300 to 1800 ms or for 350 to 1500 ms. The cycle may repeat from30 to 300, or from 50 to 250, or from 80 to 220, or from 100 to 200,times per treatment/treatment protocol. Alternatively, the cycle mayrepeat from 150 to 600, or from 190 to 550, or from 200 to 520, or from210 to 500 times per treatment. In one aspect the treatment protocol mayrepeat the same cycle. In another aspect the treatment protocol mayrepeat different cycles, wherein the cycles may be different in thenumber of sections, and/or duration of sections, and/or sequence ofactivating and/or deactivating the active elements, and/or parametersset for electromagnetic energy and/or secondary energy (e.g. shape ofenvelope, amplitude, frequency, duration and so on).

A cycle of the exemplary treatment protocol executed by the control unit11 may comprise one or more sections from the following list:

In one section, the electrode E10 delivers the RF envelope.

In another section, the electrode E18 delivers the RF envelope.

In another section, the electrode E11 delivers the RF envelope.

In another section, the electrode E15 delivers the RF envelope.

In another section, the electrode E12 delivers the RF envelope.

In another section, the electrode E1 delivers the RF envelope.

In another section, the electrode E14 delivers the RF envelope.

In another section, the electrode E7 delivers the RF envelope.

In another section, the electrode E13 delivers the RF envelope.

In another section, the electrode E8 delivers the RF envelope.

In another section, the electrode E4 delivers the RF envelope.

In another section, the electrode E3 delivers the RF envelope.

In another section, none electrode delivers the RF envelope.

In another section, the electrode E6 delivers the RF envelope.

In another section, the electrode E5 delivers the RF envelope.

In another section, the electrode E16 delivers the RF envelope.

In another section, the electrode E9 delivers the RF envelope.

In another section, the electrode E17 delivers the RF envelope.

In another section, the electrode E2 delivers the RF envelope.

The sections may be arranged one after another in specific order,wherein each section may be included in the cycle one or more times. Inone aspect some sections may not be included in the cycle (e.g. asection when none electrode delivers the RF envelope). Each protocolsection may last for 200 to 3000 ms or for 250 to 2000 ms or for 300 to1800 ms or for 350 to 1500 ms and some sections of the cycle may lastfor time t1, some sections may last for time t2, wherein the t2 ishigher than t1. In addition, some sections may last for time t3, whichis higher than t1 and t2. For example, the sections may be arranged suchthat the electrode following the previous electrode is from differentpad that the previous electrode.

The cycle may further comprise delivering of electric current (e.g. oneor more EC envelopes) by the electrode pairs of the first pad (e.g.E3-E5 and E4-E6) for a time duration of one or more sections in a row,e.g. one to seven sections, two to six sections, three to five sections,or four to five sections in a row, causing muscle contractions under thefirst pads, e.g. under the forehead pad. Therefore, the electric currentmay be delivered by the electrode pairs of the first pad (e.g. E3-E5 andE4-E6) for a time duration of 200 ms to 21 s, 250 ms to 12 s, 900 ms to9 s, 1.4 s to 7.5 s.

The cycle may further comprise delivering of electric current (e.g. oneor more EC envelopes) by the electrode pairs of the first, second andthird pad (e.g. E3-E5, E4-E6, E9-E11, E10-E12, E15-E17 and E16-E18) fora time duration of one or more sections in a row, e.g. one to sevensections, two to six sections, three to five sections, or four to fivesections in a row, causing muscle contractions under the first, secondand third pads, e.g. under the forehead pad and left and right cheekpads. Therefore, the electric current may be delivered by the electrodepairs of the first, second and third pad (e.g. E3-E5, E4-E6, E9-E11,E10-E12, E15-E17 and E16-E18) for a time duration of 200 ms to 21 s, 250ms to 12 s, 900 ms to 9 s, 1.4 s to 7.5 s.

The cycle may further comprise delivering of electric current (e.g. oneor more EC envelopes) by the electrode pairs of the second and thirdpads (e.g. E9-E11, E10-E12, E15-E17 and E16-E18) for a time duration ofone or more sections in a row, e.g. one to seven sections, two to sixsections, three to five sections, or four to five sections in a row,causing muscle contractions under the second and third pads, e.g. underthe left and right cheek pads. Therefore, the electric current may bedelivered by the electrode pairs of the second and third pad (e.gE9-E11, E10-E12, E15-E17 and E16-E18) for a time duration of 200 ms to21 s, 250 ms to 12 s, 900 ms to 9 s, 1.4 s to 7.5 s.

Throughout some sections of the cycle no electrode pairs deliver the ECenvelope, causing the muscles to relax.

The treatment protocol may be preprogrammed such that each electrodeused during the treatment may deliver the RF envelope once per cycle andsome electrode pairs (e.g. E1-E4) may deliver EC envelope twice percycle. Alternatively, each electrode may deliver the RF envelope 2 to10, or 2 to 8, or 2 to 5 times per cycle; and some electrode pairs maydeliver the EC envelope 1 to 10, or 1 to 8, or 1 to 5 times per cycle.

In one aspect, the treatment protocol may be preprogrammed such thatonly one electrode delivers the RF envelope per section. In anotheraspect, 2 to 20, or 2 to 15, or 2 to 10, or 2 to 5, or 2 to 3 electrodesdeliver RF envelopes in each section simultaneously, wherein the RFenvelopes may be the same or may be different and wherein the electrodesdelivering RF envelopes may be from different pads. In another aspect,no RF envelopes may be delivered during at least one section.

The treatment protocol may be preprogrammed such that during a singletreatment the RF envelopes are delivered 25 to 300, or 50 to 250, or 80to 200, or 100 to 180 times by each electrode with an RF pause timebetween each delivery of the RF envelope. The RF pause time—the timeduring which the electrode is not providing a radiofrequency energy tothe patient between two consecutive deliveries of RF envelopes—may be inthe range of 0.5 to 20 s, or of 1 to 15 s, or of 1.5 to 12 s, or of 2 to10 s.

In one aspect, the radiofrequency energy may be controlled by a controlunit (e.g. CPU) in order to provide a constant heating radiofrequencypower (CHRP) on each electrode, which means that each electrode provideshomogenous heating of the patient. A CHRP setting may be preprogrammedin the treatment protocol for each specific electrode in each specificpad based on the dimensions of the electrode and/or its position in thepad and/or its position on the body area of the patient. In anotheraspect, the radio frequency power may be controlled by the control unitbased on feedback from at least one thermal sensor measuring thetemperature of the treated body area and/or the temperature of theelectrode providing the radiofrequency energy such, that when thedesired temperature is reached, the electrodes are controlled to keepthe temperature at this desired level. A typical treatment temperatureof the body area under the electrode is in the range of 37.5° C. to 55°C. or in the range of 38° C. to 53° C. or in the range of 39° C. to 52°C. or in the range of 40° C. to 50° C. or in the range of 41° C. to 45°C.

The treatment protocol may be preprogrammed such that during a singletreatment the EC envelopes are delivered 25 to 1000, or 50 to 900, or100 to 750, or 120 to 600, or 150 to 500 times by at least one pair ofelectrodes with an EC pause time between each delivery of the ECenvelope. The EC pause time—the time when the electrode pair is notproviding electric current to the patient between two consecutivedeliveries of EC envelopes—may be in the range of 0.5 to 20 s, or of 1to 15 s, or of 1.5 to 12 s, or of 2 to 10 s. Alternatively, theelectrode pair may deliver EC envelopes one after another without the ECpause time.

The treatment protocol may be preprogrammed such that during at leastone section the active element 13 (e.g. electrode) provides 1 to 900electric pulses, 2 to 700 electric pulses, 10 to 500 electric pulses, 25to 400 electric pulses, 50 to 375 electric pulses, or 100 to 200electric pulses.

In another aspect, radiofrequency energy may be delivered constantlythrough all electrodes during the whole treatment and only the ECenvelopes may be delivered sequentially.

Another non limiting example of a cycle of the treatment protocolexecuted by the control unit 11 for three pads 4 providing a musclecontractions may be as follows:

The cycle may comprise delivering of electric current (e.g. one or moreEC envelopes) by the electrode pairs of the first pad (e.g. E3-E5 andE4-E6) for a time duration of one or more sections in a row, e.g. one toseven sections, two to six sections, three to five sections, or four tofive sections in a row, causing muscle contractions under the firstpads, e.g. under the forehead pad. Therefore, the electric current maybe delivered by the electrode pairs of the first pad (e.g. E3-E5 andE4-E6) for a time duration of 200 ms to 21 s, 250 ms to 12 s, 900 ms to9 s, 1.4 s to 7.5 s.

The cycle may further comprise delivering of electric current (e.g. oneor more EC envelopes) by the electrode pairs of the first, second andthird pad (e.g. E3-E5, E4-E6, E9-E11, E10-E12, E15-E17 and E16-E18) fora time duration of one or more sections in a row, e.g. one to sevensections, two to six sections, three to five sections, or four to fivesections in a row, causing muscle contractions under the first, secondand third pads, e.g. under the forehead pad and left and right cheekpads. Therefore, the electric current may be delivered by the electrodepairs of the first, second and third pad (e.g. E3-E5, E4-E6, E9-E11,E10-E12, E15-E17 and E16-E18) for a time duration of 200 ms to 21 s, 250ms to 12 s, 900 ms to 9 s, 1.4 s to 7.5 s.

The cycle may further comprise delivering of electric current (e.g. oneor more EC envelopes) by the electrode pairs of the second and thirdpads (e.g. E9-E11, E10-E12, E15-E17 and E16-E18) for a time duration ofone or more sections in a row, e.g. one to seven sections, two to sixsections, three to five sections, or four to five sections in a row,causing muscle contractions under the second and third pads, e.g. underthe left and right cheek pads. Therefore, the electric current may bedelivered by the electrode pairs of the second and third pad (e.gE9-E11, E10-E12, E15-E17 and E16-E18) for a time duration of 200 ms to21 s, 250 ms to 12 s, 900 ms to 9 s, 1.4 s to 7.5 s.

Throughout some sections of the cycle, no electrode pairs deliver the ECenvelope, causing the muscles to relax.

In one aspect the treatment protocol may be preprogramed such that eachactive element 13 (e.g. electrode, coil, heating element, fluid conduit)used during the treatment may provide heating once per cycle and someactive elements 13 (e.g. electrode, coil) may provide musclecontractions one or more times per cycle. Alternatively, each activeelement 13 may provide heating 2 to 10, 2 to 8, or 2 to 5 times percycle, and some active elements 13 may provide muscle contractions 1 to10, 1 to 8, or 1 to 5 times per cycle.

In one aspect, the treatment protocol may be preprogrammed such thatonly one active element 13 provides heating per section (e.g. byradiofrequency energy). In another aspect, 2 to 20, or 2 to 15, or 2 to10, or 2 to 5, or 2 to 3 active elements 13 provide heating in eachsection simultaneously, wherein the heating temperature may be the sameor may be different. In another aspect, heating may not be providedduring at least one section. Each protocol section may last for 200 to3000 ms or for 250 to 2000 ms or for 300 to 1800 ms or for 350 to 1500ms and some sections of the cycle may last for time t1, some sectionsmay last for time t2, wherein the t2 is higher than t1. In addition,some sections may last for time t3, which is higher than t1 and t2.

In one aspect, the treatment protocol may be preprogrammed such thatduring a single treatment the heating (e.g. by radiofrequency energy) isprovided 25 to 300, or 50 to 250, or 80 to 200, or 100 to 180 times byone or more active elements 13 with a pause time between each heating.The heating pause time—the time during which non active element 13 isproviding a heating of the patient between two consecutive heating—maybe in the range of 20 ms to 10 s, or of 50 ms to 5 s, or of 100 ms to 2s, or of 250 ms to 1 s.

In one aspect, the active elements 13 may be controlled by a controlunit (e.g. CPU) to keep the temperature at a desired level. A typicaltreatment temperature of the body area under the active elements 13 isin the range of 37.5° C. to 55° C. or in the range of 38° C. to 53° C.or in the range of 39° C. to 52° C. or in the range of 40° C. to 50° C.or in the range of 41° C. to 45° C.

The treatment protocol may be preprogrammed such that during a singletreatment the muscle contractions are provided 25 to 1000, or 50 to 900,or 100 to 750, or 120 to 600, or 150 to 500 times by at least one activeelement 13 (e.g. by providing the electric current) or at least one pairof active elements 13 with contraction pause time between each musclecontractions. One contraction may last for a duration in range of 0.1 to15 seconds or in the range of 0.5 to 12 seconds or in the range of 1 to10 seconds or in the range of 2 to 8 seconds. The contraction pausetime—the time when the at least one active element 13 or at least onepair of active elements 13 is not providing a muscle contraction betweentwo consecutive contractions may be in the range of 0.5 to 20 s, or of 1to 15 s, or of 1.5 to 12 s, or of 2 to 10 s. Alternatively the at leastone active element 13 or at least one pair of active elements 13 mayprovide contractions one after another without the contraction pausetime.

The treatment protocol may be preprogrammed such that during at leastone section the active element 13 (e.g. electrode or coil) provides 1 to900 secondary energy pulses or 2 to 700 secondary energy pulses or 10 to500 secondary energy pulses or 25 to 400 secondary energy pulses or 50to 375 secondary energy pulses or 100 to 200 secondary energy pulses.Furthermore, the treatment protocol may be preprogrammed such thatduring the treatment the active element 13 (e.g. electrode or coil)provides secondary energy envelopes 25 to 1000, or 50 to 900, or 100 to750, or 120 to 600, or 150 to 500 times.

In another aspect, heating may be provided constantly through all activeelements 13 the whole treatment and only the contractions may beprovided sequentially, for example, with contraction pause time betweeneach muscle contraction.

Yet in another aspect, the treatment or the cycle may comprise at leastone section when no energy/signal is provided to the tissue.

In one aspect, the pad may comprise one or more active elements 13 (e.g.electrode or coil) that provides more than one energy, or the pad maycomprise more different active elements 13 (e.g. electrode and coil)that provides more than one energy. For example radiofrequency energy,electric current and magnetic field, or radiofrequency energy, electriccurrent and ultrasound. Alternatively, the pad may be configured toproduce more than two therapies, for example, heating of the skin (e.g.by radiofrequency energy), contraction of muscles (e.g. by electriccurrent) and massage/relaxation of the tissue (e.g. by pressure pulses).

A single treatment may last for 1 to 60 min, or for 5 to 45 min, or for10 to 30 min, or for 15 to 25 min, or for 18 to 23 min based on thenumber of pads used during the treatment. The number of pads used insingle treatment may be 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or up to 100. Theprotocol may be preprogrammed such, that the electrodes providing theelectric current causing the muscle contractions are switched to provideradiofrequency heating after they produce one, two, three, four or fivecontractions on maximum.

The respective sections are assembled by the control unit (CPU) in thetreatment protocol to provide at least 60-900 contractions or 90-800contractions, or 150-700 contractions by a single pad per treatment.

In addition, the respective electrode pairs providing electric currentto the patient are controlled by the control unit (CPU) to provide atleast 50-1000 contractions or 60-900 contractions or 90-800contractions, or 100-450 contractions per treatment.

The forehead pad may include a layout of electrodes such that theanatomical area 1 and anatomical area 2 are stimulated by alternatingcurrents which may cause muscle contractions while anatomical area 3 isnot stimulated by alternating currents causing muscle contraction asshown in FIG. 10. The control unit (CPU) is configured to provide atreatment protocol energizing by alternating electric currents onlythose electrodes located in proximity or above the anatomical area 1 and2; and energizing electrode/electrodes in proximity of or aboveanatomical area 3 by radiofrequency energy only as shown in FIG. 10. Theanatomical area 1 and 2 may comprise the Frontalis muscles and theanatomical area 3 may comprise the center of the Procerus muscle. Theforehead pad may also treat the Corrugator supercilii muscle orOrbicularis oculi with radiofrequency energy.

The pad used for a treatment of the cheek (either side of the face belowthe eye) may include a layout of electrodes such that the anatomicalarea comprising the Buccinator muscle, the Masseter muscle, theZygomaticus muscles or the Risorius muscle are stimulated by electricalcurrents, which may cause muscle contractions, wherein the otheranatomical area may be only heated by the radiofrequency energy. A cheekpad may also be used for contraction of the Lavator labii superioris.

On the contrary the pad may be configured such that the layout ofelectrodes close to the eyes (e.g. body part comprising Orbicularisoculi muscles) or teeth (e.g. body part comprising Orbicularis or ismuscles) may not provide energy causing muscle contractions.

The pad used for a treatment of the submentum or submental area mayinclude a layout of electrodes such that the anatomical area comprisingthe Mylohyoid muscle or the Digastric muscle is stimulated withelectrical current, which may cause muscle contractions, wherein theother anatomical area may only be heated by the radiofrequency energy.In one aspect, a submentum pad (pad used for treatment of the submentum)may not provide electric current to an Adam's apple, but may provideheating with radiofrequency energy to the Adam's apple.

The treatment device may be configured such, that in each section orstep the impedance sensor provides the information about the contact ofthe pad or active element (e.g. electrode) with the patient to thecontrol unit (e.g. CPU). The impedance may be measured by the activeelement (e.g. electrode) itself. The control unit (e.g. CPU) maydetermine based on the pre-set conditions if the contact of the pad oractive element (e.g. electrode) with the patient is sufficient or not.In case of sufficient contact, the control unit (e.g. CPU) may allow thetreatment protocol to continue. In case that the contact isinappropriate, the valuated pad or active element (e.g. electrode) isturned off and the treatment protocol continues to consecutive pad oractive element (e.g. electrode) or the treatment is terminated. Thedetermination of proper contact of the pad or active element (e.g.electrode) may be displayed on the human machine interface 8.

The impedance measurement may be made at the beginning of thesection/step, during the section/step or at the end of the section/step.The impedance measurement and/or the proper contact evaluation may bedetermined only on the active electrodes for the given section/step ormay be made on all electrodes of all pads used during the section/step.

In one aspect, the impedance may be monitored through all activeelements (e.g. electrodes) while the therapy is being provided to thepatient. The device monitors the impedance between the active element(e.g. electrode) and the skin of the patient while the treatment energy(e.g. radiofrequency or electric current) is being delivered to thepatient, analyzes the monitored impedance at two or more different timeinstances in order to determine a change in the size of theelectrode-skin contact area, and if the change in the monitoredimpedance reaches a pre-determined threshold, alters the stimulationbeing delivered to the patient or terminates the treatment. The changein the impedance value at a given time may be quantified by an impedanceratio between the impedance value at that time and a baseline impedance,which is a first impedance value from the history of impedancemeasurement of a given active element (e.g. electrode).

The device may further comprise a billing system. The billing system maybe based on a reader and an information medium (e.g. card) that hasrecorded number of therapies. The information medium (e.g. card) may beput into the reader, or may work on a contactless principle, and thenthe amount of recorded number of therapies is subtracted based on theamount of used pads during the therapy. New information medium (e.g.card) may contain recorded number of therapies in a range of 1 to 100 orin a range of 2 to 80 or in a range of 5 to 50 or in a range of 10 to40. When the information medium (e.g. card) has no more recorded numberof therapies, the user may order a new information medium (e.g. card).If the pads or applicators are disposable, then the information mediummay be a part of the new pads or applicators order and the amount of therecorded number of therapies may be equal to the amount of the orderedpads or applicators. For example, if the user of the device orders 30disposable pads, the amount of recorded therapies on the informationmedium (e.g. card, which is also a part of the order) is also 30. Thereader may be part of the main unit 2, or the interconnecting block 3 orthe applicator

FIG. 7 and FIG. 8 are discussed together. FIG. 7 shows a block diagramof an apparatus for contactless therapy 100. FIG. 8 is an illustrationof an apparatus for contactless therapy 100. Apparatus for contactlesstherapy 100 may comprise two main blocks: main unit 2 and a deliveryhead 19 interconnected via fixed or adjustable arm 21.

Main unit 2 may include a primary electromagnetic generator 6 which maygenerate one or more forms of electromagnetic radiation wherein theelectromagnetic radiation may be e.g., in the form of incoherent lightor in the form of coherent light (e.g. laser light) of predeterminedwavelength. The electromagnetic field may be primarily generated by alaser, laser diode module, LED, flash lamp or incandescent light bulb.The electromagnetic radiation may be such that it may be at leastpartially absorbed under the surface of the skin of the patient. Thewavelength of the applied radiation may be in the range of 100 to 15000nm or in the range of 200 to 12000 nm or in the range of 300 to 11000 nmor in the range of 400 to 10600 nm or it may be in the form of second,third, fourth, fifth, sixth, seventh or eighth harmonic wavelengths ofthe above mentioned wavelength ranges. Main unit 2 may further comprisea human machine interface 8 represented by display, buttons, keyboard,touchpad, touch panel or other control members enabling an operator tocheck and adjust therapy and other device parameters. The power supply 5located in the main unit may include a transformer, disposable battery,rechargeable battery, power plug or standard power cord. The outputpower of the power supply 5 may be in the range of 10 W to 600 W, or inthe range of 50 W to 500 W, or in the range of 80 W to 450 W. Indicators17 may provide additional information about the current status of thedevice independently on human machine interface 8. Indicators 17 may berealized through the display, LEDs, acoustic signals, vibrations orother forms capable of adequate notice.

Delivery head 19 may be interconnected with the main unit via arm 21which may form the main optical and electrical pathway. Arm 21 maycomprise transmission media, for example wires or waveguide, e.g.mirrors or fiber optic cables, for electromagnetic radiation in the formof light or additional electric signals needed for powering the deliveryhead 19. The control unit (e.g. CPU) 11 controls the primaryelectromagnetic generator 6 which may generate a continuouselectromagnetic energy (CM) or a pulses, having a fluence in the rangeof 0.1 pJ/cm² to 1000 J/cm² or in the range of 0.5 pJ/cm² to 800 J/cm²or in the range of 0.8 pJ/cm² to 700 J/cm² or in the range of 1 pJ/cm²to 600 J/cm² on the output of the electromagnetic generator. The CM modemay be operated for a time interval in the range of 0.1 s to 24 hours orin the range of 0.2 s to 12 hours or in the range of 0.5 s to 6 hours orin the range of 1 s to 3 hours. The pulse duration of theelectromagnetic radiation operated in the pulse regime may be in therange of 0.1 fs to 2000 ms or in the range of 0.5 fs to 1500 ms or inthe range of 1 fs to 1200 ms or in the range of 1 fs to 1000 ms.Alternatively the pulse duration may be in the range of 0.1 fs to 1000ns or in the range of 0.5 fs to 800 ns or in the range of 1 fs to 500 nsor in the range of 1 fs to 300 ns. Alternatively, the pulse duration maybe in the range of 0.3 to 5000 ps or in the range of 1 to 4000 ps or inthe range of 5 to 3500 ps or in the range of 10 to 3000 ps. Oralternatively the pulse duration may be in the range of 0.05 to 2000 msor in the range of 0.1 to 1500 ms or in the range of 0.5 to 1250 ms orin the range of 1 to 1000 ms. The primary electromagnetic generator 6 inthe pulse regime may be operated by control unit (e.g. CPU) 11 in asingle shot mode or in a repetition mode or in a burst mode. Thefrequency of the repetition mode or the burst mode may be in the rangeof 0.05 to 10 000 Hz or in the range of 0.1 to 5000 Hz or in the rangeof 0.3 to 2000 Hz or in the range of 0.5 to 1000 Hz. Alternatively thefrequency of the repetition mode or the burst mode may be in the rangeof 0.1 kHz to 200 MHz or in the range of 0.5 kHz to 150 MHz or in therange of 0.8 kHz to 100 MHz or in the range of 1 kHz to 80 MHz. Thesingle shot mode may be configured to generate a single electromagneticenergy of specific parameters (e.g. intensity, duration, etc.) forirradiation of a single treatment area. The repetition mode may beconfigured to generate an electromagnetic energy, which may have one ormore specific parameters (e.g. intensity, duration, etc.), with arepetition rate of the above-mentioned frequency for irradiation of asingle treatment area. The burst mode may be configured to generatemultiple consecutive electromagnetic energys, which may have variableparameters (e.g. intensity, duration, delay etc.), during one sequence,wherein the sequences are repeated with the above-mentioned frequencyand wherein the sequence may include the same or different sets ofconsecutive electromagnetic energys.

Alternatively, the device may contain more than one primaryelectromagnetic generator 6 for generation of the same or a differentelectromagnetic energy, e.g. one primary electromagnetic generator isfor generation of an ablative electromagnetic energy and the other isfor generation of a non-ablative electromagnetic energy. In this case,it is possible for an operator to select which primary electromagneticgenerators may be used for a given treatment or the clinician can choosea required treatment through the human machine interface 8 and thecontrol unit (e.g. CPU) 11 will select which primary electromagneticgenerators will be used. It is possible to operate one or more primaryelectromagnetic generators of the device 100 simultaneously,successively or in an overlapping method. For example in the case of twoprimary electromagnetic generators: in the simultaneous method, bothprimary electromagnetic generators are used simultaneously during a timeinterval e.g., 1-20 ps. In the successive method, the first primaryelectromagnetic generator is used during the first time interval e.g.,from 1 to 10 ps. The first primary electromagnetic generator is thenstopped and the second primary electromagnetic generator is immediatelyused in a subsequent time interval e.g., from 10 to 20 ps. Such asequence of two or more successive steps may be repeated. In theoverlapping method, the first primary electromagnetic generator is usedduring a time interval, e.g., 1-10 ps, and the second primaryelectromagnetic generator is used in a second overlapping time intervalfor e.g., 2-11 ps, wherein during the second time interval the firstprimary electromagnetic generator and the second primary electromagneticgenerator are overlapping e.g., with total overlapping method time for2-10 ps. In the case of more than two primary electromagneticgenerators, the activating and deactivating of the primaryelectromagnetic generators in a successive or overlap method may bedriven by control unit (e.g. CPU) 11 in the order which is suitable fora given treatment, e.g. first activating the pre-heating primaryelectromagnetic generator, then the ablation primary electromagneticgenerator and then the non-ablative primary electromagnetic generator.

The active elements 13 in the delivery head 19 may be in the form ofoptical elements, which may be represented by one or more opticalwindows, lenses, mirrors, fibers or diffraction elements. The opticalelement representing active element 13 may be connected to or maycontain primary electromagnetic generator 6 inside the delivery head 19.The optical element may produce one beam of electromagnetic energy,which may provide an energy spot having an energy spot size defined as asurface of tissue irradiated by one beam of light. One optical elementmay provide one or more energy spots e.g. by splitting one beam into aplurality of beams. The energy spot size may be in the range of 0.001cm² to 1000 cm², or in the range of 0.005 cm² to 700 cm², or in therange of 0.01 cm² to 300 cm², or in the range of 0.03 cm² to 80 cm².Energy spots of different or the same wavelength may be overlaid or maybe separated. Two or more beams of light may be applied to the same spotat the same time or with a time gap ranging from 0.1 μs to 30 seconds.Energy spots may be separated by at least 1% of their diameter, and inaddition, energy spots may closely follow each other or may be separatedby a gap ranging from 0.01 mm to 20 mm or from 0.05 mm to 15 mm or from0.1 mm to 10 mm.

The control unit (e.g. CPU) may be further responsible for switchingbetween active elements 13 or for moving the active elements 13 withinthe delivery head 19 so that the electromagnetic radiation may bedelivered homogeneously into the whole treatment area marked with aimingbeam 18. The rate of switching between active elements 13 may bedependent on the amount of delivered energy, pulse length, etc. and thespeed of control unit (e.g. CPU) or other mechanism responsible forswitching or moving the active elements 13 (e.g. scanner). Additionally,a device may be configured to switch between multiple active elements 13in such a way that they deliver energy simultaneously, successively orin an overlapping method. For example, in the case of two activeelements: in the simultaneous method, both active elements are usedsimultaneously during the time interval e.g., 1-20 ps. In the successivemethod, the first active element is used during the first time intervale.g., from 1 to 10 ps. The first active element is then stopped and thesecond active element is immediately used in a subsequent time intervale.g., from 10 to 20 ps. This successive step may be repeated. In theoverlapping method, the first active element is used during a timeinterval for e.g., 1-10 ps, and the second active element is used in asecond overlapping time interval for e.g., 2-11 ps, wherein during thesecond time interval the first active element and the second activeelement are overlapping e.g., with total overlapping method time for2-10 ps.

The aiming beam 18 has no clinical effect on the treated tissue and mayserve as a tool to mark the area to be treated so that the operatorknows which exact area will be irradiated and the control unit 11 (e.g.CPU) may set and adjust treatment parameters accordingly. An aiming beammay be generated by a separate electromagnetic generator or by theprimary electromagnetic generator 6. Aiming beam 18 may deliver energyat a wavelength in a range of 300-800 nm and may supply energy at amaximum power of 10 mW.

In addition, the pad may contain a control unit 11 (e.g. CPU) drivendistance sensor 22 for measuring a distance from active element 13 tothe treated point within the treated area marked by aiming beam 18. Themeasured value may be used by CPU 11 as a parameter for adjusting one ormore treatment parameters which may depend on the distance between theactive element and a treating point, e.g. fluence. Information fromdistance sensor 22 may be provided to control unit 11 (e.g. CPU) beforeevery switch/movement of an active element 13 so that the deliveredenergy will remain the same across the treated area independent of itsshape or unevenness.

The patient's skin may be pre-cooled to a selected temperature for aselected duration over at least one treatment portion, the selectedtemperature and duration for pre-cooling preferably being sufficient tocool the skin to at least a selected temperature below normal bodytemperature. The skin may be cooled to at least the selected temperatureto a depth below the at least one depth for the treatment portions sothat the at least one treatment portion is substantially surrounded bycooled skin. The cooling may continue during the application ofradiation, wherein the duration of the application of radiation may begreater than the thermal relaxation time of the treatment portions.Cooling may be provided by any known mechanism including water cooling,sprayed coolant, presence of an active solid cooling element (e.g.thermoelectric cooler) or air flow cooling. A cooling element may act asan optical element. Alternatively, a spacer may serve as a coolingelement. Cooling may be provided during, before or after the treatmentwith electromagnetic energy. Cooling before treatment may also providean environment for sudden heat shock, while cooling after treatment mayprovide faster regeneration after heat shock. The temperature of thecoolant may be in the range of −200° C. to 36° C. The temperature of thecooling element during the treatment may be in the range of −80° C. to36° C. or −70° C. to 35° C. or −60° C. to 34° C. or −20° C. to 30° C. or0° C. to 27° C. or 5° C. to 25° C. Further, where the pad is not incontact with the patient's skin, cryogenic spray cooling, gas flow orother non-contact cooling techniques may be utilized. A cooling gel onthe skin surface might also be utilized, either in addition to orinstead of, one of the cooling techniques indicated above.

Additionally, device 100 may include one or more sensors. The sensor mayprovide information about at least one physical quantity and itsmeasurement may lead to feedback which may be displayed by human machineinterface 8 or indicators 17. The one or more sensors may be used forsensing a variety of physical quantities, including but not limited tothe energy of the delivered electromagnetic radiation or backscatteredelectromagnetic radiation from the skin, impedance of the skin,resistance of the skin, temperature of the treated skin, temperature ofthe untreated skin, temperature of at least one layer of the skin, watercontent of the device, the phase angle of delivered or reflected energy,the position of the active elements 13, the position of the deliveryelement 19, temperature of the cooling media or temperature of theprimary electromagnetic generator 6. The sensor may be a temperature,acoustic, vibration, electric, magnetic, flow, positional, optical,imaging, pressure, force, energy flux, impedance, current, Hall orproximity sensor. The sensor may be a capacitive displacement sensor,acoustic proximity sensor, gyroscope, accelerometer, magnetometer,infrared camera or thermographic camera. The sensor may be invasive orcontactless. The sensor may be located on the delivery element 19 or inthe main unit 2 or may be a part of a distance sensor 22. One sensor maymeasure more than one physical quantity. For example, a sensor mayinclude a combination of a gyroscope, an accelerometer or amagnetometer. Additionally, the sensor may measure one or more physicalquantities of the treated skin or untreated skin.

The thermal sensor measures and monitors the temperature of the treatedskin. The temperature can be analyzed by a control unit 11 (e.g. CPU).The thermal sensor may be a contactless sensor (e.g. infraredtemperature sensor). The control unit 11 (e.g. CPU) may also usealgorithms to calculate a temperature below the surface of the skinbased on the surface temperature of the skin and one or more additionalparameters. A temperature feedback system may control the temperatureand based on set or pre-set limits alert the operator in humanperceptible form e.g. on the human machine interface 8 or via indicators17. In a limit temperature condition, the device may be configured toadjust treatment parameters of each active element, e.g. output power,activate cooling or stop the treatment. Human perceptible form may be asound, alert message shown on human machine interface 8 or indicators 17or change of color of any part of the device 100.

A resistance sensor may measure the skin resistance, since it may varyfor different patients, as well as the humidity—wetness and sweat mayinfluence the resistance and therefore the behavior of the skin in theenergy field. Based on the measured skin resistance, the skin impedancemay also be calculated.

Information from one or more sensors may be used for generation of apathway on a convenient model e.g. a model of the human body shown on adisplay of human machine interface 8. The pathway may illustrate asurface or volume of already treated tissue, presently treated tissue,tissue to be treated, or untreated tissue. A convenient model may show atemperature map of the treated tissue providing information about thealready treated tissue or untreated tissue.

The sensor may provide information about the location of bones, inflamedtissue or joints. Such types of tissue may not be targeted byelectromagnetic radiation due to the possibility of painful treatment.Bones, joints or inflamed tissue may be detected by any type of sensorsuch as an imaging sensor (ultrasound sensor, IR sensor), impedance andthe like. A detected presence of these tissue types may cause generalhuman perceptible signals or interruption of generation ofelectromagnetic radiation. Bones may be detected for example by a changeof impedance of the tissue or by analysis of reflected electromagneticradiation.

Furthermore, the device 100 may include an emergency stop button 16 sothat the patient can stop the therapy immediately anytime during thetreatment.

It may be part of the invention that the method of treatment includesthe following steps: preparation of the tissue; positioning the proposeddevice; selecting or setting up the treatment parameters; andapplication of the energy. More than one step may be executedsimultaneously.

Preparation of the tissue may include removing make-up or cleansing thepatient's skin. For higher target temperatures, anesthetics may beapplied topically or in an injection.

Positioning the device may include selecting the correct shape of thepad according to the area to be treated and affixing the pad or theneutral electrode to the patient, for example with an adhesive layer,vacuum suction, band or mask, and verifying proper contact with thetreated tissue in the case of contact therapy. In the case ofcontactless therapy, positioning of the device may include adjusting theaiming beam of proposed device so that the device can measure thedistance of the active element(s) from the treatment area and adjust thetreatment parameters accordingly.

Selecting or setting up the treatment parameters may include adjustingtreatment time, power, duty cycle, delivery time and mode (CM orpulsed), active points surface density/size for fractional arrangementand mode of operation. Selecting the mode of operation may mean choosingsimultaneous, successive or overlapping methods or selecting theswitching order of active elements or groups of active elements orselecting the proper preprogrammed protocol.

Application of the energy may include providing at least one type ofenergy in the form of RF energy, electric current, ultrasound energy orelectromagnetic energy in the form of polychromatic or monochromaticlight, or their combination. The energy may be provided from at leastone active element into the skin by proposed device. Energy may bedelivered and regulated automatically by the control unit (e.g. CPU)according to information from thermal sensors and impedance measurementsand, in the case of contactless therapy, distance sensors. All automaticadjustments and potential impacts on the therapy may be indicated on thedevice display. Either the operator or the patient may suspend therapyat any time during treatment. A typical treatment might have a durationof about 1 to 60 min or 2 to 50 min or 3 to 40 min or 5 to 30 min or 8to 25 min or 10 to 20 min depending on the treated area and the size andnumber of active elements located within one or more pads. A typicaltreatment with 1, 2, 3, 4, 5 or up to 10 pads may have a total durationof about 1 to 60 minutes or 2 to 50 minutes or 3 to 40 minutes 5 to 30minutes or 8 to 25 minutes or 10 to 20 minutes. A typical treatment withone pad may have a total duration of about 1 to 30 minutes or 2 to 25minutes or 3 to 22 minutes 5 to 20 minutes or 5 to 15 minutes or 5 to 12minutes.

In one example, application of energy to the tissue may includeproviding radiofrequency energy and/or electric current and/orultrasound energy or any combination of these, from the active elementsembedded in the pad, to the skin of the patient. In such embodiment,active elements providing radiofrequency energy are capacitive orresistive RF electrodes and the RF energy may cause heating, coagulationor ablation of the skin. The electric current is provided by the RFelectrodes and may cause muscle contractions. Ultrasound energy may beprovided through an acoustic window and may rise the temperature in thedepth which may suppress the gradient loss of RF energy and thus thedesired temperature in a germinal layer may be reach. In addition, theRF electrode may act as an acoustic window for ultrasound energy.

Alternatively, the application of the energy to the tissue may includeproviding electromagnetic energy in the form of polychromatic ormonochromatic light from the active elements into the skin of thepatient. In such case, active elements providing the electromagneticenergy may comprise optical elements described in the proposed device.Optical elements may be represented by an optical window, lens, mirror,fiber or electromagnetic field generator, e.g. LED, laser, flash lamp,incandescent light bulb or other light sources known in the state ofart. The electromagnetic energy in the form of polychromatic ormonochromatic light may entail the heating, coagulation or ablation ofthe skin in the treated area.

After reaching the required temperature and therapy time the therapy isterminated, the device accessories may be removed and a cleansing of thepatient's skin may be provided.

1. A device for treatment of a patient comprising: a primaryelectromagnetic generator generating an electromagnetic energy; asecondary generator generating a secondary energy; at least one activeelement attached to the treatment area configured to provideelectromagnetic energy from the primary electromagnetic generator or thesecondary energy from the secondary generator to the treatment area; acontrol unit comprising one or more preprogrammed protocols; wherein thecontrol unit is configured to control the primary electromagneticgenerator, the secondary energy generator and the at least one activeelement; wherein the device is configured to provide the electromagneticenergy and the secondary energy to the treatment area according to theone or more preprogrammed protocols.